Recalls / —

—#50981

Product

CoaguChek brand PT Test Strips; U.S. Catalog Number 3116247 (48 strip pack-professional use).

FDA product code

GJS — Test, Time, Prothrombin

Device class

Class 2

Medical specialty

Hematology

510(k) numbers

K930454, K962571, K974569, K994349

Affected lot / code info

Lots 469A and 475A; exp. 6/30/2008.

Why it was recalled

The product was erroneously distributed to home users in contrast to its use for healthcare professionals only.

Root cause (FDA determination)

Other

Action the firm took

All consignees were notified by telephone on/or about 2/28/07 and some received a follow-up letter dated 3/2/07 or 3/5/07.

Recalling firm

Firm

Roche Diagnostics Corp.

Address

9115 Hague Rd, Indianapolis, Indiana 46250-0416

Distribution

Distribution pattern

Nationwide-California, Georgia, Louisiana, Maryland, Oklahoma and Texas.

Timeline

Recall initiated

2007-02-28

Posted by FDA

2007-04-11

Terminated

2007-06-13

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #50981. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.