—#29333

Product

Roche/Hitachi brand lactate reagent for the quantitative determination of L-lactate in plasma, cerebrospinal fluid or whole blood. Catalog # 1822837.

FDA product code: LNN
Affected lot / code info: All lots of reagent when used manually or on the Roche/Hitachi 902, 911, 912, 917 or Modular Analytics P module analyzers.

Why it was recalled

Patient samples with very high lactate values may falsely be reported as within the normal range without the instrument giving a warning flag to the technician.

Root cause (FDA determination)

Other

Action the firm took

Recall letters were sent to U.S. customers on 9/2/03 instructing them not to run lactate with these analyzers. An update notification letter was sent on or about 9/18/03 telling customers to discontinue use of the product for manual lactate determinations.

Recalling firm

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

Distribution

Distribution pattern: United States, Canada and Germany

Timeline

Recall initiated: 2003-09-02
Posted by FDA: 2003-10-15
Terminated: 2003-12-10
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #29333. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.