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).
FDA Recall Z-0399-2012 · Posted 2012-01-11
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Recalling FirmBio-Rad Laboratories, Inc.
Recall StatusTerminated
Product CodeKRZ
Date Initiated2011-10-25
Date Terminated2012-02-02
Product Quantity63
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.
Firm 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.
Root Cause
Process control
Distribution Pattern
Nationwide Distribution including MI, SC, OH, IL, MN, MD, VA, NY and WI.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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