Recall Z-1259-2011 ยท LCP Assay, Glycosylated Hemoglobin
Bio-Rad Laboratories Inc
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.
| Date | Feb 15, 2011 (initiated Feb 19, 2010) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Nonconforming Material/Component |
| Action | 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 RESPON |
| Quantity | 27 |
| Distribution | Worldwide distribution: USA including states of: OH, MN, SC and VA; and country including: Japan. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K070819 | VARIANT II TURBO LINK HEMOGLOBIN A1C PROGRAM, AND VARIANT II TURBO LINK HEMOGLOBIN TESTING WITH MODEL, 270-2716, Bio-Rad Laboratories Inc., Clinical Systems Divisi, Jun 25, 2007 |