Recall Z-3159-2011 ยท LCP Assay, Glycosylated Hemoglobin
Bio-Rad Laboratories, Inc.
VARIANT II TURBO Link Hemoglobin A1c Program Reorder Pack. Calibrator/Diluent Set. IVD. Kit components: Elution Buffer A, 2 x 2500 mL Elution Buffer B, 1 x 2100 mL Wash/Diluent Solution, 1 x 2500 mL Cartridge Set, 2 Cation exchange Analytical Cartridges, 4 Cation Guard Cartridges; CD-ROM - Calibration/Diluent Set, 2 levels, 2 vials each of lyophilized human red blood cell hemolysate with preservat
| Date | Sep 6, 2011 (initiated Jul 28, 2011) |
| Status | Terminated |
| Reason | The Elution Buffer B, lot no. GA 10430, was shipped in a 2.0 L bottle instead of the standard 2.5 L bottle. |
| Root cause | Employee error |
| Action | The firm, BIO-RAD, sent a "Medical Device Correction" letter dated July 28, 2011 to all consignees/customers via Fed Ex on August 8, 2011. The letter described the product, problem and actions to be taken. The customers were informed that they could continue to use and report results with the affected buffer lot and the stability studies will continue until lot expiration date. The consignees were instructed to distribute this letter to all customers that have received the affected lot and to distribute the MEDICAL DEVICE CORRECTION RESPONSE FORM only to those customers that request replaceme |
| Quantity | 40 |
| Distribution | Nationwide distribution: MD, MI, MN, NY, OH, SC, VA and WI. |
| 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 |