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Terminated

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

FDA Recall Z-0028-04 · Posted 2003-10-15

Recalling FirmRoche Diagnostics Corp.
Recall StatusTerminated
Product CodeLNN
Date Initiated2003-09-02
Date Terminated2003-12-10
Product Quantity21958

Reason for Recall

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.

Firm Action

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.

Root Cause

Other

Distribution Pattern

United States, Canada and Germany

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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