Z-1969-2011

Bio Rad brand D-10 Hemoglobin A1c Program Reorder Pack, which contains Update Kit D-10 A1c Program Diskette...

Name: Z-1969-2011 Bio Rad brand D-10 Hemoglobin A1c Program Reorder Pack, which contains Update Kit D-10 A1c Program Diskette...
Creator: Bio-Rad Laboratories, Inc., Hercules, CA
Published: 2010-09-08
License: https://open.fda.gov/license/

Bio-Rad Laboratories Inc. / initiated 2010-09-08 / Terminated / root cause: labeling and UDI

FDA source

Bio-Rad Laboratories, Inc., Hercules, CA began a recall of Bio Rad brand D-10 Hemoglobin A1c Program Reorder Pack, which contains Update Kit D-10 A1c Program Diskette; Model Numbers: 220-0101 (Reorder Pack); 220-0115... on 2010-09-08. The reason FDA records is "The firm discovered that the Update Kit Floppy Diskette included in the reorder pack was mislabeled with an incorrect Lot Number for the Calibrator/Diluent Set as: S01819; The correct Lot Number for the...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1969-2011
Status: Terminated
Initiated: 2010-09-08
Posted: 2011-04-13
Terminated: 2011-06-29
Recalling firm: Bio-Rad Laboratories Inc.
Product: Bio Rad brand D-10 Hemoglobin A1c Program Reorder Pack, which contains Update Kit D-10 A1c Program Diskette; Model Numbers: 220-0101 (Reorder Pack); 220-0115 (Program Diskette); Distributed and manufactured by: Bio-Rad Laboratories, Inc., Hercules, CA System Overview: The Bio-Rad D-10 Hemoglobin Testing System provides an integrated method for the separation and determination of the relative percent of specific hemoglobins (e.g., A2, F, A1 c) in whole blood. The separation is based on the principles of high performance liquid chromatography. Technology Overview: The D-10 Hemoglobin Testing System is a single module designed for hemoglobin analysis in mid-volume laboratories. The D-10 is a fully integrated system for sample dilution, processing and analysis of hemoglobin, designed for use with specific Bio-Rad reagent kits. The D-1 0 incorporates the use of a dedicated software system for instrument control, data collection and analysis. The D-10 Software performs reduction of raw data collected from each analysis. Reagent Kit Information: The D-10 Hemoglobin A1c Program utilizes principles of ion-exchange High-performance liquid chromatography (HPLC). The D-10 Hemoglobin Ale Program is based on chromatographic separation of HbA1c on a cation exchange cartridge. The Bio-Rad D-10 Hemoglobin Ale Program is intended for the percent determination of hemoglobin A1 c in human whole blood using ion-exchange high-performance liquid chromatography (HPLC). The Bio-Rad D-10 Hemoglobin A1c Program is intended for Professional Use Only. The D-10 Hemoglobin A1c Program is for use only with the Bio-Rad D-10 Hemoglobin Testing System.
Product code: LCP Assay, Glycosylated Hemoglobin
Reason for recall: The firm discovered that the Update Kit Floppy Diskette included in the reorder pack was mislabeled with an incorrect Lot Number for the Calibrator/Diluent Set as: S01819; The correct Lot Number for the Calibrator/Diluent Set is: S01704.
Root cause tag: labeling and UDI
FDA root cause: Other
Action: The Bio-Rad Laboratories, Inc, sent a Medical Device Correction letter dated 9/8/10, to all affected customers via Federal Express addressing this mislabeling issue, a new Update Kit Floppy Diskette, Lot No. BA02210 has been produced, and Bio-Rad requests that you please destroy the Lot No. AA01815. If you have any questions please contact your regional Bio-Rad office. You may also call (510) 724-7000.
Distribution: Nationwide Distribution including : PA, OH, MO, CA, TX, FL, MA, MD, KY, OH, MI, NJ, and WA.
Product codes and lots: Lot 20001814; Exp. February 28,2012

Product code LCP

K031043Class IID-10 Hemoglobin A1cBio-Rad Laboratories, Inc. / cleared 2003-08-27

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)