FDA Medical Device Recalls (openFDA)
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 preservative, 1 bottle of diluent, 100 mL, deionized water Whole Blood Primer, 6 x 1 mL Sample Vials, 2 x 100 Instruction Manual. Bio-Rad Laboratories Inc. Hercules, CA 94547 Intended for the percent determination of hemoglobin A1c in human whole blood using ion-exchange high-performance liquid chromatography (H LPC).
- Recall number
- Z-3159-2011
- Recalling firm
- Bio-Rad Laboratories, Inc.
- Product
- 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 preservative, 1 bottle of diluent, 100 mL, deionized water Whole Blood Primer, 6 x 1 mL Sample Vials, 2 x 100 Instruction Manual. Bio-Rad Laboratories Inc. Hercules, CA 94547 Intended for the percent determination of hemoglobin A1c in human whole blood using ion-exchange high-performance liquid chromatography (H LPC).
- Status
- Terminated
- Initiated
- 2011-07-28
- Posted
- 2011-09-06
- Terminated
- 2011-11-01
- 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 replacement Elution Buffer B. In addition, the customers were to complete and return the MEDICAL DEVICE CORRECTION RESPONSE FORM via fax to (510) 741-3954, Attention: BIO-Rad CSD Regulatory Affairs Department. If you have any questions, please contact your regional Bio-Rad office or 510-724-7000.
- Quantity
- 40
- Distribution
- Nationwide distribution: MD, MI, MN, NY, OH, SC, VA and WI.
- Lot, serial or model codes
- Catalog Number: 270-2716; Reorder Pack Lot No: 70210702; Expires September 30, 2011. Elution Buffer B: Lot number 270-2718, lot number: GA10430, Exp 2/29/2012.
- 510(k) numbers
- ["K070819"]
- PMA numbers
- not on file
- Product code
- LCP
- 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