Bio-Rad Laboratories, Inc.: Medical Device Recall in 2014 - (Recall #: Z-0965-2014)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2014.

Data Source: FDA.

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.

Product Classification:

Class III

Date Initiated: November 22, 2013

Date Posted: February 19, 2014

Recall Number: Z-0965-2014

Event ID: 66947

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.

Status: Terminated

Product Quantity: 2906 kits (318 Kits in US; 2588 kits internationally)

Code Information:

Catalog number: 220-0201: Reorder Pack Lot No./Expiration date: 20030322 3/31/2014 20030337 3/31/2014 64000081 5/31/2014 64000331 5/31/2014 64000332 5/31/2014 64000888 08/31/2014 64001344 04/30/2014 64002239 11/30/2014 ( 64002240 08/3112014 64002241 11/30/2014

Distribution Pattern:

Worldwide Distribution - USA (nationwide) and Internationally to Latin America, Asia Pacific, Canada, Australia, New Zealand and India.

Voluntary or Mandated:

Voluntary: Firm initiated