Z-1377-04

Abbott Clinical Chemistry AEROSET/ ARCHITECT c8000 Creatinine. List No. 7D64-20

Name: Z-1377-04 Abbott Clinical Chemistry AEROSET/ ARCHITECT c8000 Creatinine. List No. 7D64-20
Creator: Abbott Laboratories Diagnostic Div
Published: 2004-07-27
License: https://open.fda.gov/license/

Abbott Medical / initiated 2004-07-27 / Terminated

FDA source

Abbott Laboratories Diagnostic Div began a recall of Abbott Clinical Chemistry AEROSET/ ARCHITECT c8000 Creatinine. List No. 7D64-20 on 2004-07-27. The reason FDA records is "Precipitate formed in product". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1377-04
Status: Terminated
Initiated: 2004-07-27
Posted: 2004-08-17
Terminated: 2012-05-02
Recalling firm: Abbott Medical
Product: Abbott Clinical Chemistry AEROSET/ ARCHITECT c8000 Creatinine. List No. 7D64-20
Product code: CGX Alkaline Picrate, Colorimetry, Creatinine
Reason for recall: Precipitate formed in product.
FDA root cause: Other
Action: Firm sent recall letters requesting destruction of kits in the field on July 27, 2004.
Quantity in commerce: 758
Distribution: Nationwide and to Mexico, Columbia, Ecuador, Brazil, Puerto Rico, Domincan Republic, Canada, Germany, Singapore, Hong Kong, India, Thailand, Australia, New Zealand, Bahamas.
Product codes and lots: Lot 14032HW00 Exp November 17, 2005 and lot 17054HW00 Exp November 17, 2005.

Product code CGX

K981799Class IICreaAbbott Laboratories / cleared 1998-07-22

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)