Recall Z-0965-2014— Bio-Rad Laboratories, Inc.

Name: FDA recall Z-0965-2014
Creator: U.S. Food and Drug Administration
Published: 2013-11-22

Class III · Terminated

Class III FDA medical device recall by Bio-Rad Laboratories, Inc., initiated 2013-11-22, terminated 2014-03-20. It names one FDA 510(k) clearance: K031043. Product: D-10 Dual Program, which contains Update Kit D-10 A1c program diskette. United States; Bio-Rad Laboratories, Hercules, CA 94547 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, Ale} in whole blood. The separation is based on the principles of high performance liquid chromatography.. Reason: D-10 A1c Dual Program Floppy was programmed incorrectly and cartridge injections counts are not being updated correctly when switching between the D-10 Dual Short Program and Extended Program on the D-10 Hemoglobin Testing System..

Recalling firm: Bio-Rad Laboratories, Inc.
Classification: Class III
Status: Terminated
Initiated: 2013-11-22
Terminated: 2014-03-20
Firm location: Hercules, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K031043 — D-10 HEMOGLOBIN A1CBio-Rad Laboratories, Inc.·cleared 2003-08-27

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

D-10 Dual Program, which contains Update Kit D-10 A1c program diskette. United States; Bio-Rad Laboratories, Hercules, CA 94547 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, Ale} in whole blood. The separation is based on the principles of high performance liquid chromatography.

Reason for recall

D-10 A1c Dual Program Floppy was programmed incorrectly and cartridge injections counts are not being updated correctly when switching between the D-10 Dual Short Program and Extended Program on the D-10 Hemoglobin Testing System.

Data sourced from openFDA. This site is unofficial and independent of the FDA.