Medical Device Recall #29400 | Medicaldevicehub

CFRES ID:	80552
Device Name:	N/A
Product RES Number:	Z-1901-2010
Event Date Initiated:	2009-01-22
Event Date Posted:	2010-06-25
Event Date Created:	N/A
Event Date Terminated:	2011-03-22
Recall Status:	Terminated
Res Event Number:	51498
Product Code:	LCP
K Numbers:	["K984268"]
PMA Numbers:	N/A
Product Description:	VARIANT II Hemoglobin Testing System with CDM 3.5 Software Version 3.5; Model Number: 270-2000; Product is manufactured and distributed by Bio-Rad Laboratories, Diagnostics Group, Hercules, CA. Provides an integrated method for sample preparation, separation and determination of the relative percent of specific hemoglobins in whole blood.
Code Info:	All units of these models.
Recalling Firm:	Bio-Rad Laboratories Inc
Firm FEI Number:	N/A
Adress 1:	4000 Alfred Nobel Dr
Adress 2:	N/A
City:	Hercules
State:	CA
Postal Code:	94547-1803
Additional Contact Info:	Jackie Buckley 510-724-7000
Reason for Recall:	Sample test results for the first run appears to be correct but all subsequent results during that run were assigned incorrect barcode and tube position.
Root Cause Description:	Software design
Other Submission Description:	N/A
Action:	Bio-Rad Laboratories, Inc. issued and "Urgent: Medical Device Correction" dated January 22, 2009 to all affected consignees by FED EX, followed up by telephone calls for those not responding. Consignees were instructed on proper steps to take in dealing with the affected product. Further communication will follow to provide a solution. For further information, contact Bio-Rad Laboratories at 1-510-724-7000.
Product Quantity:	N/A
Distribution Pattern:	Worldwide Distribution -- United States, Argentina, Australia, Brazil, Canada, Chile, China, Columbia, Costa Rica, Czech Republic, France, Germany, Hong Kong, Hungary, India, Italy, Mexico, New Zealand, Poland, Singapore, South Korea, Sweden, Taiwan, Thailand and the United Kingdom.
Medical Speciality Description:	N/A
Regulation Number:	N/A
Event Date Posted:	2010-06-25
Device Class:	N/A
Open FDA:	{"k_number"=>["K811567", "K880673", "K051200", "K984268", "K802721", "K093548", "K010748", "K831837", "K820076", "K802832", "K113437", "K994045", "K893453", "K862556", "K070452", "K872852", "K121366", "K802432", "K181915", "K142789", "K991850", "K082275", "K983726", "K896582", "K895661", "K912748", "K121492", "K823869", "K180509", "K811710", "K141944", "K170147", "K031539", "K791365", "K974491", "K171650", "K800794", "K790583", "K983253", "K822867", "K874749", "K033674", "K000239", "K073309", "K991246", "K080618", "K011434", "K162281", "K033847", "K904814", "K931183", "K003120", "K151809", "K001392", "K780819", "K173127", "K031380", "K013465", "K133803", "K902457", "K871679", "K063643", "K992085", "K902455", "K926469", "K854010", "K962597", "K933287", "K983172", "K920820", "K791135", "K800857", "K900718", "K050178", "K070734", "K781948", "K984529", "K990899", "K851636", "K063306", "K120199", "K860572", "K081269", "K812242", "K990992", "K934070", "K882051", "K100547", "K930823", "K140829", "K020235", "K170623", "K023654", "K896334", "K963844", "K893224", "K830935", "K946274", "K921831", "K801561", "K111128", "K133344", "K980888", "K183230", "K110934", "K012410", "K020532", "K834294", "K852986", "K041764", "K941616", "K992921", "K920449", "K160762", "K011933", "K832087", "K871388", "K791103", "K130860", "K882222", "K030553", "K913614", "K952337", "K942009", "K884184", "K063400", "K951361", "K091400", "K891235", "K100304", "K063209", "K780573", "K070819", "K011852", "K131307", "K802233", "K801289", "K880698", "K875354", "K935613", "K821360", "K023763", "K072686", "K833356", "K081895", "K122472", "K973696", "K003280", "K091711", "K042193", "K921676", "K120497", "K792086", "K862371", "K873428", "K040872", "K042459", "K050574", "K000887", "K102510", "K791777", "K110056", "K820279", "K161533", "K991483", "K053411", "K062658", "K904027", "K852111", "K140827", "K961674", "K810714", "K940971", "K921305", "K021897", "K090413", "K112015", "K130990", "K972265", "K896830", "K141750", "K192987", "K833772", "K052464", "K000885", "K801422", "K936204", "K060650", "K955087", "K102914", "K140801", "K791428", "K920397", "K090699", "K122101", "K791642", "K110188", "K163633", "K896335", "K822977", "K905709", "K051321", "K911625", "K110313", "K021484", "K842689", "K993131", "K864643", "K905513", "K971919", "K102045", "K973365", "K071466", "K861697", "K192369", "K832775", "K031296", "K936285", "K881863", "K031043", "K781851", "K072714", "K803186", "K884315", "K041444", "K790046", "K810958", "K833805", "K060001", "K071132", "K831478", "K022661", "K811000", "K012525", "K031042", "K920198", "K130014", "K925204", "K901414", "K993590", "K020234", "K142664", "K810638", "K121842", "K940143", "K041635"], "registration_number"=>["8043889", "2085064", "8023024", "1423455", "3004146366", "2517506", "2084025", "1832216", "3004111573", "9610126", "3006198300", "3005146313", "3004493545", "9613069", "1832816", "3015525148", "9610529", "3012133212", "9611444", "1220649", "3016438761", "2950409", "1627187", "3002637618", "3011826360", "3023162659", "3015798231", "2030861", "2027969", "3003539867", "2954361", "3007662974", "3003795116", "3004192065", "1717966", "2432235", "3008959428", "1931251", "3003917514", "8031673", "3011061417", "1616487", "3003422726", "3002809144", "3017548799", "2050012", "1064608", "8020890", "8023060", "3013660430", "9610633", "3012526002", "1825740", "3004529019", "2434178", "3000148879", "2032900", "1181121", "1827821", "2050010", "3014375716", "3003460426", "9680746", "3009448641", "2915274", "3005333358", "3010825766", "1220972", "3005529799", "3008178161", "2247288", "3004145393", "3006697287", "8020316", "9612316", "3020068406"], "fei_number"=>["6387", "3004146366", "2517506", "2084025", "3002806560", "3000215862", "1000125596", "1832216", "3004111573", "3006198300", "3003071743", "3003992026", "3005146313", "3004493545", "1832816", "3002806559", "1000122044", "3002807423", "3012133212", "3004445302", "1627187", "1220649", "3016438761", "3023162659", "3002637618", "3002806809", "3011826360", "1000123732", "3015798231", "3002940409", "1000206808", "3007662974", "3003795116", "3004192065", "1717966", "2432235", "3008959428", "1931251", "3003917514", "3003045237", "3011061417", "3006769061", "1616487", "3003422726", "2967", "3002809144", "3017548799", "2050012", "3013660430", "1825740", "3012526002", "3004529019", "2434178", "3000148879", "1181121", "3000206414", "3002698769", "1827821", "3014375716", "3003460426", "2050010", "3009448641", "3002808328", "3005333358", "3010825766", "3003206796", "1220972", "3005529799", "3008178161", "2915274", "3004145393", "3006697287", "3002806693", "1000135102", "3020068406"], "device_name"=>"Assay, Glycosylated Hemoglobin", "medical_specialty_description"=>"Hematology", "regulation_number"=>"864.7470", "device_class"=>"2"}

CFRES ID:

80552

Device Name:

N/A

Product RES Number:

Z-1901-2010

Event Date Initiated:

2009-01-22

Event Date Posted:

2010-06-25

Event Date Created:

N/A

Event Date Terminated:

2011-03-22

Recall Status:

Terminated

Res Event Number:

51498

Product Code:

LCP

K Numbers:

["K984268"]

PMA Numbers:

N/A

Product Description:

VARIANT II Hemoglobin Testing System with CDM 3.5 Software Version 3.5; Model Number: 270-2000; Product is manufactured and distributed by Bio-Rad Laboratories, Diagnostics Group, Hercules, CA. Provides an integrated method for sample preparation, separation and determination of the relative percent of specific hemoglobins in whole blood.

Code Info:

All units of these models.

Recalling Firm:

Bio-Rad Laboratories Inc

Firm FEI Number:

N/A

Adress 1:

4000 Alfred Nobel Dr

Adress 2:

N/A

City:

Hercules

State:

CA

Postal Code:

94547-1803

Additional Contact Info:

Jackie Buckley 510-724-7000

Reason for Recall:

Sample test results for the first run appears to be correct but all subsequent results during that run were assigned incorrect barcode and tube position.

Root Cause Description:

Software design

Other Submission Description:

N/A

Action:

Bio-Rad Laboratories, Inc. issued and "Urgent: Medical Device Correction" dated January 22, 2009 to all affected consignees by FED EX, followed up by telephone calls for those not responding. Consignees were instructed on proper steps to take in dealing with the affected product. Further communication will follow to provide a solution. For further information, contact Bio-Rad Laboratories at 1-510-724-7000.

Product Quantity:

N/A

Distribution Pattern:

Worldwide Distribution -- United States, Argentina, Australia, Brazil, Canada, Chile, China, Columbia, Costa Rica, Czech Republic, France, Germany, Hong Kong, Hungary, India, Italy, Mexico, New Zealand, Poland, Singapore, South Korea, Sweden, Taiwan, Thailand and the United Kingdom.

Medical Speciality Description:

N/A

Regulation Number:

N/A

Event Date Posted:

2010-06-25

Device Class:

N/A

Open FDA:

{"k_number"=>["K811567", "K880673", "K051200", "K984268", "K802721", "K093548", "K010748", "K831837", "K820076", "K802832", "K113437", "K994045", "K893453", "K862556", "K070452", "K872852", "K121366", "K802432", "K181915", "K142789", "K991850", "K082275", "K983726", "K896582", "K895661", "K912748", "K121492", "K823869", "K180509", "K811710", "K141944", "K170147", "K031539", "K791365", "K974491", "K171650", "K800794", "K790583", "K983253", "K822867", "K874749", "K033674", "K000239", "K073309", "K991246", "K080618", "K011434", "K162281", "K033847", "K904814", "K931183", "K003120", "K151809", "K001392", "K780819", "K173127", "K031380", "K013465", "K133803", "K902457", "K871679", "K063643", "K992085", "K902455", "K926469", "K854010", "K962597", "K933287", "K983172", "K920820", "K791135", "K800857", "K900718", "K050178", "K070734", "K781948", "K984529", "K990899", "K851636", "K063306", "K120199", "K860572", "K081269", "K812242", "K990992", "K934070", "K882051", "K100547", "K930823", "K140829", "K020235", "K170623", "K023654", "K896334", "K963844", "K893224", "K830935", "K946274", "K921831", "K801561", "K111128", "K133344", "K980888", "K183230", "K110934", "K012410", "K020532", "K834294", "K852986", "K041764", "K941616", "K992921", "K920449", "K160762", "K011933", "K832087", "K871388", "K791103", "K130860", "K882222", "K030553", "K913614", "K952337", "K942009", "K884184", "K063400", "K951361", "K091400", "K891235", "K100304", "K063209", "K780573", "K070819", "K011852", "K131307", "K802233", "K801289", "K880698", "K875354", "K935613", "K821360", "K023763", "K072686", "K833356", "K081895", "K122472", "K973696", "K003280", "K091711", "K042193", "K921676", "K120497", "K792086", "K862371", "K873428", "K040872", "K042459", "K050574", "K000887", "K102510", "K791777", "K110056", "K820279", "K161533", "K991483", "K053411", "K062658", "K904027", "K852111", "K140827", "K961674", "K810714", "K940971", "K921305", "K021897", "K090413", "K112015", "K130990", "K972265", "K896830", "K141750", "K192987", "K833772", "K052464", "K000885", "K801422", "K936204", "K060650", "K955087", "K102914", "K140801", "K791428", "K920397", "K090699", "K122101", "K791642", "K110188", "K163633", "K896335", "K822977", "K905709", "K051321", "K911625", "K110313", "K021484", "K842689", "K993131", "K864643", "K905513", "K971919", "K102045", "K973365", "K071466", "K861697", "K192369", "K832775", "K031296", "K936285", "K881863", "K031043", "K781851", "K072714", "K803186", "K884315", "K041444", "K790046", "K810958", "K833805", "K060001", "K071132", "K831478", "K022661", "K811000", "K012525", "K031042", "K920198", "K130014", "K925204", "K901414", "K993590", "K020234", "K142664", "K810638", "K121842", "K940143", "K041635"], "registration_number"=>["8043889", "2085064", "8023024", "1423455", "3004146366", "2517506", "2084025", "1832216", "3004111573", "9610126", "3006198300", "3005146313", "3004493545", "9613069", "1832816", "3015525148", "9610529", "3012133212", "9611444", "1220649", "3016438761", "2950409", "1627187", "3002637618", "3011826360", "3023162659", "3015798231", "2030861", "2027969", "3003539867", "2954361", "3007662974", "3003795116", "3004192065", "1717966", "2432235", "3008959428", "1931251", "3003917514", "8031673", "3011061417", "1616487", "3003422726", "3002809144", "3017548799", "2050012", "1064608", "8020890", "8023060", "3013660430", "9610633", "3012526002", "1825740", "3004529019", "2434178", "3000148879", "2032900", "1181121", "1827821", "2050010", "3014375716", "3003460426", "9680746", "3009448641", "2915274", "3005333358", "3010825766", "1220972", "3005529799", "3008178161", "2247288", "3004145393", "3006697287", "8020316", "9612316", "3020068406"], "fei_number"=>["6387", "3004146366", "2517506", "2084025", "3002806560", "3000215862", "1000125596", "1832216", "3004111573", "3006198300", "3003071743", "3003992026", "3005146313", "3004493545", "1832816", "3002806559", "1000122044", "3002807423", "3012133212", "3004445302", "1627187", "1220649", "3016438761", "3023162659", "3002637618", "3002806809", "3011826360", "1000123732", "3015798231", "3002940409", "1000206808", "3007662974", "3003795116", "3004192065", "1717966", "2432235", "3008959428", "1931251", "3003917514", "3003045237", "3011061417", "3006769061", "1616487", "3003422726", "2967", "3002809144", "3017548799", "2050012", "3013660430", "1825740", "3012526002", "3004529019", "2434178", "3000148879", "1181121", "3000206414", "3002698769", "1827821", "3014375716", "3003460426", "2050010", "3009448641", "3002808328", "3005333358", "3010825766", "3003206796", "1220972", "3005529799", "3008178161", "2915274", "3004145393", "3006697287", "3002806693", "1000135102", "3020068406"], "device_name"=>"Assay, Glycosylated Hemoglobin", "medical_specialty_description"=>"Hematology", "regulation_number"=>"864.7470", "device_class"=>"2"}

Detailed Result for Z-1901-2010