RecallDepth

Clinical Chemistry Uric Acid; LN 7D76-20

This recall has been terminated (originally issued July 20, 2004).

Company
Abbott Laboratories Diagnostic Div
Recall Initiated
March 18, 2004
Posted
July 20, 2004
Terminated
February 10, 2012
Recall Number
Z-0769-04
Quantity
796 kits.
Firm Location
South Pasadena, CA
Official Source
View on FDA website ↗

Reason for Recall

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

Distribution

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

Lot / Code Info

Lot number: 95015HW00

Root Cause

Other

Action Taken

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.

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