FDA Medical Device Recalls (openFDA)
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 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).
- Recall number
- Z-0399-2012
- Recalling firm
- Bio-Rad Laboratories, Inc.
- 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).
- Status
- Terminated
- Initiated
- 2011-10-25
- Posted
- 2012-01-11
- Terminated
- 2012-02-02
- 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.
- Lot, serial or model codes
- Catalog number: 270-2716: Lot 70211322; 70211432, 70211440; exp 3/31/2012
- 510(k) numbers
- ["K070819"]
- PMA numbers
- not on file
- Product code
- KRZ
- Firm FEI
- 2915274
- Firm city
- Hercules
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28