Recalls / —

—#34087

Product

Roche brand Reflotron GOT (AST), 30 test strips; catalog # 745120.

FDA product code

CKD — Hydrazone Colorimetry, Alt/Sgpt

Device class

Class 1

Medical specialty

Clinical Chemistry

510(k) numbers

K870246

Affected lot / code info

Lots 23665132; exp 5/31/2005 and 23665231; exp 6/30/2005.

Why it was recalled

Coating defect may result is falsely decreased patient and/or control results.

Root cause (FDA determination)

Other

Action the firm took

Recall letters dated 7/14/04 were sent to each customer asking that use of these lots be stopped immediately. Testing labs were asked to notify the attending physician for any patients tested with these test strips.

Recalling firm

Firm

Roche Diagnostics Corp.

Address

9115 Hague Rd, Indianapolis, Indiana 46256-1025

Distribution

Distribution pattern

United States.

Timeline

Recall initiated

2004-07-14

Posted by FDA

2004-07-31

Terminated

2004-10-14

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #34087. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.