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

FDA device recall Z-0965-2014 · posted 2014-02-10 · Terminated

Recall details

Recalling firm

Bio-Rad Laboratories, Inc.

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.

Action taken

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.

Root cause

Software design

Status

Terminated

Product code

LCP

Quantity affected

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.

Date initiated

2013-11-22

Date posted

2014-02-10

Date terminated

2014-03-20

Location

Hercules, CA

Related 510(k) clearances