Z-0965-2014Class III

D-10 Dual Program, which contains Update Kit D-10 A1c program diskette. United States; Bio-Rad Laboratories...

Name: Z-0965-2014 D-10 Dual Program, which contains Update Kit D-10 A1c program diskette. United States; Bio-Rad Laboratories...
Creator: Bio-Rad Laboratories, Inc.
Published: 2013-11-22
License: https://open.fda.gov/license/

Bio-Rad Laboratories Inc. / initiated 2013-11-22 / Terminated / root cause: software

FDA source

Bio-Rad Laboratories, Inc. began a recall of 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... on 2013-11-22. FDA classified it as Class III and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-0965-2014
Classification: Class III
Status: Terminated
Initiated: 2013-11-22
Posted: 2014-02-10
Terminated: 2014-03-20
Recalling firm: Bio-Rad Laboratories Inc.
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.
Product code: LCP Assay, Glycosylated Hemoglobin
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.
Root cause tag: software
FDA root cause: Software design
Action: BIO-RAD sent an Urgent Medical Device Correction letter dated November 22, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to continue to use the affected update kit disk(s) included with the reorder pack(s), but manually track the number of injections on the cartridge, reviewing QC results closely throughout the life of the reorder pack or destroy the affected disk(s) included with these reorder pack(s) and replace with the new Update Kit disk(s) The new Update Kit disks will elminate the problem and may be used with all reorder packs. The replacement disks do not contain reagent or calibrator information; after installing teh new Update Kit disk, they ust manually update the component information using instructions provided with the disk. For questions regarding this recall call 510-741-6265.
Quantity in commerce: 2906 kits (318 Kits in US; 2588 kits internationally)
Distribution: Worldwide Distribution - USA (nationwide) and Internationally to Latin America, Asia Pacific, Canada, Australia, New Zealand and India.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0965-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0965-2014	Class III	Terminated	Voluntary: Firm initiated	2014-02-19	2014-02-10

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)