Z-1342-2011

Bio Rad brand VARIANT II TURBO Hemoglobin A1c Program Reorder Pack, Model Number/Catalog No.: 270-2417, which...

Name: Z-1342-2011 Bio Rad brand VARIANT II TURBO Hemoglobin A1c Program Reorder Pack, Model Number/Catalog No.: 270-2417, which...
Creator: Bio-Rad Laboratories Inc
Published: 2010-03-24
License: https://open.fda.gov/license/

Bio-Rad Laboratories Inc. / initiated 2010-03-24 / Terminated / root cause: manufacturing process

FDA source

Bio-Rad Laboratories Inc began a recall of Bio Rad brand VARIANT II TURBO Hemoglobin A1c Program Reorder Pack, Model Number/Catalog No.: 270-2417, which contains the update kit CD-ROM, Model/Catalog... on 2010-03-24. The reason FDA records is "The firm received customer complaints associated with the Update Kit CD-ROM not being able to generate a valid calibration after being uploaded, resulting in patient results not being generated". 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-1342-2011
Status: Terminated
Initiated: 2010-03-24
Posted: 2011-02-17
Terminated: 2011-03-04
Recalling firm: Bio-Rad Laboratories Inc.
Product: Bio Rad brand VARIANT II TURBO Hemoglobin A1c Program Reorder Pack, Model Number/Catalog No.: 270-2417, which contains the update kit CD-ROM, Model/Catalog No.: 270-2423, Distributed and Manufactured by: Bio-Rad Laboratories, Inc., Hercules, CA. Intended for the percent determination of hemoglobin A1c in human whole blood using ion-exchange high-performance liquid chromatography (HPLC).
Product code: LCP Assay, Glycosylated Hemoglobin
Reason for recall: The firm received customer complaints associated with the Update Kit CD-ROM not being able to generate a valid calibration after being uploaded, resulting in patient results not being generated.
Root cause tag: manufacturing process
FDA root cause: Other
Action: Medical Device Correction letter dated March 24, 2010 was sent to customers. The letter identified the affected product and explained the reason for recall. Customers were asked to destroy Lot No. AA00190 and replace it with the Lot No. AA00838 CD-ROM that is enclosed with the letter. Customers are to complete and fax back the Medical Device Correction Response Form at the number provided.
Quantity in commerce: 48 units
Distribution: Worldwide Distribution -- USA and Italy.
Product codes and lots: Lot Numbers: 70200185. Lot Nos.: 70200185, AA00190

Product code LCP

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)