Z-0399-2012

VARIANT II Link Hemoglobin A1c Program Reorder Pack, 1600 tests, IVD, For the determination of Hemoglobin A1c...

Name: Z-0399-2012 VARIANT II Link Hemoglobin A1c Program Reorder Pack, 1600 tests, IVD, For the determination of Hemoglobin A1c...
Creator: Bio-Rad Laboratories, Inc.
Published: 2011-10-25
License: https://open.fda.gov/license/

Bio-Rad Laboratories Inc. / initiated 2011-10-25 / Terminated / root cause: manufacturing process

FDA source

Bio-Rad Laboratories, Inc. began a recall of 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... on 2011-10-25. The reason FDA records is "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". 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-0399-2012
Status: Terminated
Initiated: 2011-10-25
Posted: 2012-01-11
Terminated: 2012-02-02
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).
Product code: KRZ Calibrator For Hemoglobin And Hematocrit Measurement
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.
Root cause tag: manufacturing process
FDA 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 in commerce: 63
Distribution: Nationwide Distribution including MI, SC, OH, IL, MN, MD, VA, NY and WI.
Product codes and lots: Catalog number: 270-2716: Lot 70211322; 70211432, 70211440; exp 3/31/2012

Product code KRZ

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)