Recall Z-0399-2012 ยท KRZ Calibrator For Hemoglobin And Hematocrit Measurement
Bio-Rad Laboratories, Inc.
VARIANT II Link Hemoglobin A1c Program Reorder Pack, 1600 tests, IVD, For the determination of Hemoglobin A1c in human whole blood. Contents: Elution Buffer A , 1 x 2500 mL Elution Buffer B, 1 x 2100 mL Wash/Diluent Solution, 1 x 2500 mL Cartridge Set CD ROM - 1 Calibrator/Diluent Set Whole Blood Primer, 6 x 1 mL Sample vials, 2 x 100 Instruction Manual Bio-Rad Laboratories, Inc., 400 Alfred nob
| Date | Jan 11, 2012 (initiated Oct 25, 2011) |
| Status | Terminated |
| Reason | It was discovered that the Variant II Turbo Link Calibrator Values card contains incorrect values for IFCC units. The numbers are missing a decimal point. |
| Root cause | Process control |
| Action | Bio-Rad Laboratories, Inc. sent a Medical Device Correction Notification letter dated October 25, 2011, via Federal Express to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. The correction was initiated by the firm, customers were instructed to contact their regional Bio-Rad office for any questions. For questions regarding this recall call 510-741-6114. |
| Quantity | 63 |
| Distribution | Nationwide Distribution including MI, SC, OH, IL, MN, MD, VA, NY 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 |