Z-3159-2011

VARIANT II TURBO Link Hemoglobin A1c Program Reorder Pack. Calibrator/Diluent Set. IVD. Kit components...

Name: Z-3159-2011 VARIANT II TURBO Link Hemoglobin A1c Program Reorder Pack. Calibrator/Diluent Set. IVD. Kit components...
Creator: Bio-Rad Laboratories, Inc.
Published: 2011-07-28
License: https://open.fda.gov/license/

Bio-Rad Laboratories Inc. / initiated 2011-07-28 / Terminated / root cause: manufacturing process

FDA source

Bio-Rad Laboratories, Inc. began a recall of 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... on 2011-07-28. The reason FDA records is "The Elution Buffer B, lot no. GA 10430, was shipped in a 2.0 L bottle instead of the standard 2.5 L bottle". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-3159-2011
Status: Terminated
Initiated: 2011-07-28
Posted: 2011-09-06
Terminated: 2011-11-01
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).
Product code: LCP Assay, Glycosylated Hemoglobin
Reason for recall: 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 tag: manufacturing process
FDA 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 in commerce: 40
Distribution: Nationwide distribution: MD, MI, MN, NY, OH, SC, VA and WI.
Product codes and lots: 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.

Product code LCP

K070819Class IIVariant II Turbo Link Hemoglobin A1c Program, and Variant II Turbo Link Hemoglobin Testing with Model, 270-2716,Bio-Rad Laboratories Inc., Clinical Systems Divisi / cleared 2007-06-25

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)