—#69519

Product

Roche/Hitachi Modular Analytics System, Modular D Module GMMI clinical chemistry analyzer; Catalog number 03284522001. Intended for qualitative and quantitative in vitro determinations using a wide variety of tests. Roche Diagnostics Corporation, 9115 Hague Road, Indianapolis, IN, 46250

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 08-02.

Why it was recalled

Possible mismatch between patient and result.

Root cause (FDA determination)

Process change control

Action the firm took

Consignees were notified via Urgent Medical Device Correction letter dated 3/21/08, which instructed them to not manually order QC test selections while the system is in operation mode and that they can only manually order QC when the system is in Stand-by mode. Consignees are instructed to consult with their physicians or pathologist to determine specific clinical implications for their patients. The firm states that this issue will be resolved in the next version of software.

Recalling firm

Firm: Roche Diagnostics Corp.
Address: 9115 Hague Rd, Indianapolis, Indiana 46250-0416

Distribution

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

Timeline

Recall initiated: 2008-03-21
Posted by FDA: 2008-08-13
Terminated: 2009-11-18
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #69519. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.