Z-0769-04

Clinical Chemistry Uric Acid; LN 7D76-20

Name: Z-0769-04 Clinical Chemistry Uric Acid; LN 7D76-20
Creator: Abbott Laboratories Diagnostic Div
Published: 2004-03-18
License: https://open.fda.gov/license/

Abbott Medical / initiated 2004-03-18 / Terminated

FDA source

Abbott Laboratories Diagnostic Div began a recall of Clinical Chemistry Uric Acid; LN 7D76-20 on 2004-03-18. The reason FDA records is "Unacceptable upward drift of results in control runs within 24 hour period". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0769-04
Status: Terminated
Initiated: 2004-03-18
Posted: 2004-07-20
Terminated: 2012-02-10
Recalling firm: Abbott Medical
Product: Clinical Chemistry Uric Acid; LN 7D76-20
Product code: CDO Acid, Uric, Uricase (U.V.)
Reason for recall: Unacceptable upward drift of results in control runs within 24 hour period.
FDA root cause: Other
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.
Quantity in commerce: 796 kits.
Distribution: Nationwide and Mexico, Equador, Puerto Rico, Hong Kong, Bahamas, Venezuela, Argentina, Canada, New Zealand, Columbia, Brazil, England, Trinidad.
Product codes and lots: Lot number: 95015HW00

Product code CDO

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)