Recalls / —

—#37073

Product

Roche COBAS INTEGRA HBA1c Kits for use with COBAS INTEGRA 400, 400+, 700 and 800 analyzers; catalog 20753521322.

FDA product code

LCP — Assay, Glycosylated Hemoglobin

Device class

Class 2

Medical specialty

Hematology

510(k) numbers

K003120

Affected lot / code info

Lots 660587, 659867, 657295, 657344, 658498, 656157, 655052, 653288, 653424, 652153, 650988, 650430, 650119, 649291, 647186, 646336, 644962, 643398 and 642104.

Why it was recalled

The product is not uniform across the cassettes of some lots, which will result in an inconsistent bias of patient results.

Root cause (FDA determination)

Other

Action the firm took

Recall letters dated 2/15/05 were sent to each user instructing customers to run controls before the use of each cassette or kit in a lot, instead of once per lot as previously instructed, and to notify the physician at the facility.

Recalling firm

Firm

Roche Diagnostics Corp.

Address

9115 Hague Rd, Indianapolis, Indiana 46256-1025

Distribution

Distribution pattern

Nationwide.

Timeline

Recall initiated

2005-02-15

Posted by FDA

2005-03-23

Terminated

2005-05-17

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #37073. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.