—#74896

Product

Roche/Hitachi Modular Analytics System, clinical chemistry analyzer, Modular P Module, Roche Diagnostics Corp., Indpls., IN; GMMI No. 03284549001. Is a fully automatic, computerized chemistry analyzer intended for in vitro quantitative and qualitative determinations of a wide range analytes. The instrument is capable of performing potentiometric and photometric assays.

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 with software version 08-03.

Why it was recalled

If a masked module is unmasked during the reagent registration process, the calibration parameters may be assigned to the wrong reagents, resulting in the reporting of incorrect control and sample results.

Root cause (FDA determination)

Software change control

Action the firm took

Consignees were notified via an Urgent Medical Device Correction letter dated 11/12/08 and instructed to only execute "module unmasking" when the unit is in "standby" mode and to consult with their physicians at the facility to determine the clinical implications and whether any clinical intervention is needed for patients treated based upon results obtained with this software. Questions should be directed to Roche Diagnostics Technical Support at 1-800-428-2336.

Recalling firm

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

Distribution

Distribution pattern: Nationwide Distribution -- including states of California, Florida, Georgia, Hawaii, Indiana, Maryland, New York, North Carolina, Pennsylvania, and Virginia.

Timeline

Recall initiated: 2008-11-12
Posted by FDA: 2009-04-10
Terminated: 2009-09-22
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #74896. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.