Class 3 Device Recall BioRad D10 Hemoglobing Testing System

• Date Initiated by Firm: September 08, 2010
• Date Posted: April 13, 2011
• Recall Status: Terminated on June 29, 2011
• Recall Number: Z-1969-2011
• Recall Event ID: 56807
• 510(K)Number: K031043
• Product Classification: Assay, glycosylated hemoglobin - Product Code LCP
• 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.
• Code Information: Lot 20001814; Exp. February 28,2012
• Recalling Firm/ Manufacturer: Bio-Rad Laboratories, Inc., Hercules, CA; 4000 Alfred Nobel Dr; Hercules CA 94547-1803
• For Additional Information Contact: Jackie Buckley; 510-724-7000
• Manufacturer 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.
• FDA Determined 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = LCP and Original Applicant = BIO-RAD LABORATORIES, INC.