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Terminated

Clinical Chemistry Uric Acid; LN 7D76-20

FDA Recall Z-0769-04 · Posted 2004-07-20

Recalling FirmAbbott Laboratories Diagnostic Div
Recall StatusTerminated
Product CodeCDO
Date Initiated2004-03-18
Date Terminated2012-02-10
Product Quantity796 kits.

Reason for Recall

Unacceptable upward drift of results in control runs within 24 hour period.

Firm Action

Firm sent recall letters 3/18/2004 suggesting destruction and/or running QC tests every eight hours instead of every 24 hours as is in labeling.

Root Cause

Other

Distribution Pattern

Nationwide and Mexico, Equador, Puerto Rico, Hong Kong, Bahamas, Venezuela, Argentina, Canada, New Zealand, Columbia, Brazil, England, Trinidad.

Official Source

View FDA Recall →

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

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