—#26068

Product

COBAS INTEGRA Creatinine Jaffe for use on the INTEGRA 400, 700 and 800 analyzers; system ID # 0764345, catalog # 20764345

510(k) numbers: K951595
Affected lot / code info: lot 639106

Why it was recalled

After a cassette change, patient results and controls may be up to 40% too low or too high due to calibration factor variation.

Root cause (FDA determination)

Other

Action the firm took

An urgent product removal bulletin dated 2/14/03 was sent to each affected customer advising them to discontinue use of this lot, to discard any product on hand, and to contact Roche for replacement.

Recalling firm

Firm: Roche Diagnostics Corp.
Address: 9115 Hague Road, Indianapolis, Indiana 46250-0457

Distribution

Distribution pattern: United States

Timeline

Recall initiated: 2003-02-13
Posted by FDA: 2003-03-21
Terminated: 2003-03-20
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #26068. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.