Z-0627-03

AFP Control Kit distributed under the following label: AxSYM and IMx, Abbott Laboratories USA, North Chicago...

Name: Z-0627-03 AFP Control Kit distributed under the following label: AxSYM and IMx, Abbott Laboratories USA, North Chicago...
Creator: Abbott Health Products, Inc.
Published: 2002-12-13
License: https://open.fda.gov/license/

Abbott Diagnostic International, Ltd. / initiated 2002-12-13 / Terminated / root cause: labeling and UDI

FDA source

Abbott Health Products, Inc. began a recall of AFP Control Kit distributed under the following label: AxSYM and IMx, Abbott Laboratories USA, North Chicago, IL 60064 on 2002-12-13. The reason FDA records is "Results lower than package insert ranges". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0627-03
Status: Terminated
Initiated: 2002-12-13
Posted: 2003-03-06
Terminated: 2004-06-02
Recalling firm: Abbott Diagnostic International, Ltd.
Product: AFP Control Kit distributed under the following label: AxSYM and IMx, Abbott Laboratories USA, North Chicago, IL 60064
Product code: JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Reason for recall: Results lower than package insert ranges
Root cause tag: labeling and UDI
FDA root cause: Other
Action: Device Recall Letters were mailed to all Abbott customers World Wide on 12/11/02. The letter instructed to check their inventory for the recalled product, discontinue use and destroy it according to their laboratory procedures. If the product was forwarded to another laboratory, please provide them with a copy of the letter.
Quantity in commerce: 826 kits
Distribution: Distribution nationwide and Japan, Singapore, Australia, New Zealand, and Great Britain
Product codes and lots: Product list number: 9C05-10 Lot No.: 91533Q100 Exp. date: 10/20/2003

Product code JJE

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)