—#27322

Product

Roche/Hitachi Modular Analytics P clinical chemistry analyzer; Modular P. Catalog number 766-8156.

510(k) numbers: K953239
Affected lot / code info: All units with current software versions (v 06-06 and 07-01).

Why it was recalled

Incorrect results, without a data flag, reported if one of the other reagent containers becomes depleted before the R1 reagent is depleted.

Root cause (FDA determination)

Other

Action the firm took

Customers were notified by certified mail on or about May 12, 2003. Operators were given a workaround (assure R1 has the lower number of tests remaining before using the analyzer) until new software is supplied.

Recalling firm

Firm: Roche Diagnostics Corp.
Address: 9115 Hague Road, Indianapolis, Indiana 46250-0457

Distribution

Distribution pattern: United States

Timeline

Recall initiated: 2003-05-08
Posted by FDA: 2003-10-15
Terminated: 2003-12-09
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #27322. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.