—#30856

Product

Roche brand OMNI 5 Analyzer; catalog numbers GD0395 and GD0395R.

FDA product code: JJE — Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Device class: Class 1
Medical specialty: Clinical Chemistry
510(k) numbers: K945915, K954018
Affected lot / code info: All units.

Why it was recalled

The firm is withdrawing claims that pleural, pericardial, ascitic and cerebrospinal fluids are appropriate sample types for use on these instruments.

Root cause (FDA determination)

Other

Action the firm took

A recall letter dated 12/29/03 was issued to each customer instructing them not to use the listed sample types.

Recalling firm

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

Distribution

Distribution pattern: United States.

Timeline

Recall initiated: 2003-12-29
Posted by FDA: 2004-07-20
Terminated: 2004-02-20
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #30856. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.