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Terminated

COBAS INTEGRA Creatinine Jaffe for use on the INTEGRA 400, 700 and 800 analyzers; system ID # 0764345, catalog # 20764345

FDA Recall Z-0667-03 · Posted 2003-03-21

Recalling FirmRoche Diagnostics Corp.
Recall StatusTerminated
Date Initiated2003-02-13
Date Terminated2003-03-20
Product Quantity1905

Reason for Recall

After a cassette change, patient results and controls may be up to 40% too low or too high due to calibration factor variation.

Firm Action

An urgent product removal bulletin dated 2/14/03 was sent to each affected customer advising them to discontinue use of this lot, to discard any product on hand, and to contact Roche for replacement.

Root Cause

Other

Distribution Pattern

United States

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K951595ROCHE COBAS INTEGRA ANALYZER, REAGENT CASSETTESRoche Diagnostic Systems, Inc. · 1995-09-08

Official Source

View FDA Recall →

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

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