Recall Z-0399-2012
Bio-Rad Laboratories, Inc. · initiated October 25, 2011
Product
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 nobel Drive, Hercules, CA 94547-1803. Intended for the percent determination of hemoglobin A1c in human whole blood using ion-exchange high-performance liquid chromatography (HLCP).
Codes / lots: Catalog number: 270-2716: Lot 70211322; 70211432, 70211440; exp 3/31/2012
Reason for recall
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.
FDA-determined cause: Process control
Action taken
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.
Details
- Recall number
- Z-0399-2012
- Initiated
- October 25, 2011
- Posted by FDA
- January 11, 2012
- Terminated
- February 2, 2012
- Product code
- KRZ – Calibrator For Hemoglobin And Hematocrit Measurement
- Quantity
- 63
- Distribution
- Nationwide Distribution including MI, SC, OH, IL, MN, MD, VA, NY and WI.
- Recalling firm
- Bio-Rad Laboratories, Inc., Hercules, CA