Z-0240-04

AEROSET/ARCHITECT c8000 Urea Nitrogen Models: 7D75-01; 7D75-20; 7D75-30

Name: Z-0240-04 AEROSET/ARCHITECT c8000 Urea Nitrogen Models: 7D75-01; 7D75-20; 7D75-30
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 AEROSET/ARCHITECT c8000 Urea Nitrogen Models: 7D75-01; 7D75-20; 7D75-30 on 2003-11-24. The reason FDA records is "False low results may occur with out error codes due to substrate depletion in samples with more than 220mg/dL BUN". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0240-04
Status: Terminated
Initiated: 2003-11-24
Posted: 2003-12-18
Terminated: 2012-01-25
Recalling firm: Abbott Medical
Product: AEROSET/ARCHITECT c8000 Urea Nitrogen Models: 7D75-01; 7D75-20; 7D75-30
Product code: CDQ Urease And Glutamic Dehydrogenase, Urea Nitrogen
Reason for recall: False low results may occur with out error codes due to substrate depletion in samples with more than 220mg/dL BUN.
FDA root cause: Other
Action: Firm sent letter to customers dated November 24,2003 which includes a new package insert to use with this reagent. Instructions were changed to correct low resulting situation. Subrecall was requested.
Quantity in commerce: All lots.
Distribution: Nationwide and Mexico, Brazil, Germany, Singapore, Grand Cayman, Venezuela, Puerto Rico, Hong Kong, Australia, Columbia, Dominican Republic, China, Trinidad, Argentina, Canada, New Zealand, Bahamas
Product codes and lots: All lots.

Product code CDQ

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)