Z-0550-04

Clinical Chemistry Urea Nitrogen

Name: Z-0550-04 Clinical Chemistry Urea Nitrogen
Creator: Abbott Laboratories Diagnostic Div
Published: 2003-11-24
License: https://open.fda.gov/license/

Abbott Medical / initiated 2003-11-24 / Terminated

FDA source

Abbott Laboratories Diagnostic Div began a recall of Clinical Chemistry Urea Nitrogen on 2003-11-24. The reason FDA records is "Low results due to contaminant". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0550-04
Status: Terminated
Initiated: 2003-11-24
Posted: 2004-02-26
Terminated: 2012-02-07
Recalling firm: Abbott Medical
Product: Clinical Chemistry Urea Nitrogen
Reason for recall: Low results due to contaminant.
FDA root cause: Other
Action: Each domestic customer will receive the recall letter by direct mailing. Foreign affiliates will be responsible for distributing letters to thier customers. Letters were sent 11/24/2003. A reply form was enclosed.
Quantity in commerce: 568
Distribution: Nationwide, Mexico, Argentina, Germany, Australia, Venezuela, Puerto Rico, Singapore, New Zealand, Columbia, Canada, Hong Kong, Grand Cayman
Product codes and lots: Lots: 05073HW00 04022Hw00 03041HW00

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)