—#72486

Product

Roche/Hitachi Modular E Module immunoassay analyzer, Roche Diagnostics, Ind., IN; GMMI Nos. 04998642001 and 03617505001.

FDA product code: JJE — Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Device class: Class 1
Medical specialty: Clinical Chemistry
510(k) numbers: K961481
Affected lot / code info: All units with software version 08-02.

Why it was recalled

A software bug may result in pipetting from an incorrect reagent pack and/or assigning calibration curve parameters incorrectly.

Root cause (FDA determination)

Other

Action the firm took

The consignees were notified of the problem via letter dated 6/24/08 and were provided instructions for a workaround.

Recalling firm

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

Distribution

Distribution pattern: Nationwide Distribution --- including states of Florida, New Jersey and North Carolina.

Timeline

Recall initiated: 2008-06-24
Posted by FDA: 2008-10-22
Terminated: 2009-10-22
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #72486. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.