Bio-Rad Variant II Turbo Link Hemoglobin Testing System, including Hemoglobin A, Program Reorder Pack 1600 Tests, Program Buffer A, Buffer B, Cartridge Set, Analytical Cartridge, Guard Cartridge, Calibrator, Accessory Box, Instruction Manual and Quick Guide Intended use: Measurement of Hemoglobin A1c in human whole blood.
- Company
- Bio-Rad Laboratories Inc
- Recall Initiated
- February 19, 2010
- Posted
- February 15, 2011
- Terminated
- March 3, 2011
- Recall Number
- Z-1259-2011
- Quantity
- 27
- Firm Location
- Hercules, CA
Reason for Recall
The results from the blood device had the occurrence of some ramping baselines on their chromatograms. The ramping baseline can affect quantitation of the blood results.
Distribution
Worldwide distribution: USA including states of: OH, MN, SC and VA; and country including: Japan.
Lot / Code Info
Catalog No. 270-2716 Lot No. 70291030, expiration date 2/28/2010 Lot No. 70392119, expiration date 3/31/2010 Lot No. 70292119R, expiration date 3/31/2010
Root Cause
Nonconforming Material/Component
Action Taken
The firm, Bio-Rad Laboratories, Inc., sent an "URGENT: MEDICAL DEVICE CORRECTION" letter dated February 5, 2010, to all customers and letter dated February 16, 2010 to subsidiaries via Fed-Ex or by fax. The letter described the product, problem and action to be taken by the customers. The customers were instructed to review there chromatograms form the lots listed and compare them to what documented; follow the noted instructions; destroy reorder packs from the affected lots if a ramping baseline issue is observed, and complete and return the attached CUSTOMER MEDICAL DEVICE CORRECTION RESPONSE FORM via fax to (510) 741-3954, attention: Bio-Rad CSD Regulatory Affairs Department. If you have any questions, please contact your regional Bio-Rad Office or (510)724-7000.