—#30751

Product

Roche brand OMNI 9 clinical chemistry analyzer; catalog numbers GD0475, GD0475R and GD047591.

FDA product code: JJE — Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Device class: Class 1
Medical specialty: Clinical Chemistry
510(k) numbers: K972733
Affected lot / code info: All units with software version 5.61 or below.

Why it was recalled

If the sample volume is insufficient, the analyzer may issue erroneous results without any indication to the user that the problem is insufficient sample volume.

Root cause (FDA determination)

Other

Action the firm took

Consignees were notified by letter mailed on or about December 15, 2003. Customers are instructed to assure an adequate sample volume until new software becomes available.

Recalling firm

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

Distribution

Distribution pattern: United States.

Timeline

Recall initiated: 2003-12-15
Posted by FDA: 2004-01-10
Terminated: 2004-08-02
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #30751. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.