—#34285

Product

Roche/Hitachi Modular Analytical D Module DAT clinical chemistry analyzer; catalog number 04429338160.

FDA product code: JJE — Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Device class: Class 1
Medical specialty: Clinical Chemistry
510(k) numbers: K953239
Affected lot / code info: All units.

Why it was recalled

A software defect will allow the reporting out of believable, but clinically significant, erroneous results under certain conditions.

Root cause (FDA determination)

Other

Action the firm took

Recall letters dated 8/6/04 were sent to each customer advising them of the problem and giving instructions on how to avoid it.

Recalling firm

Firm: Roche Diagnostics Corp.
Address: 9115 Hague Rd, Indianapolis, Indiana 46256-1025

Distribution

Distribution pattern: United States.

Timeline

Recall initiated: 2004-08-06
Posted by FDA: 2004-09-02
Terminated: 2006-06-26
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #34285. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.