Z-0274-04

The AXSYM System, Clinical Chemistry Analyzer, Manufactured by Abbott Laboratories, Irving, Texas

Name: Z-0274-04 The AXSYM System, Clinical Chemistry Analyzer, Manufactured by Abbott Laboratories, Irving, Texas
Creator: Abbott Laboratories, Inc
Published: 2003-10-29
License: https://open.fda.gov/license/

Abbott Medical / initiated 2003-10-29 / Terminated

FDA source

Abbott Laboratories, Inc began a recall of The AXSYM System, Clinical Chemistry Analyzer, Manufactured by Abbott Laboratories, Irving, Texas on 2003-10-29. The reason FDA records is "Potential for a contaminated Reaction Vessel (RV) or previously used RV to remain on the AxSYM System". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0274-04
Status: Terminated
Initiated: 2003-10-29
Posted: 2003-12-25
Terminated: 2007-11-13
Recalling firm: Abbott Medical
Product: The AXSYM System, Clinical Chemistry Analyzer, Manufactured by Abbott Laboratories, Irving, Texas
Product code: JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Reason for recall: Potential for a contaminated Reaction Vessel (RV) or previously used RV to remain on the AxSYM System.
FDA root cause: Other
Action: All current US AxSYM System consignees will receive the Device Correction letter via direct mailing. A 100% effectiveness check will be performed against AxSYM consignees not responding, via Customer Reply Form. An electronic copy of the Device Correction letter and communication package will be provided to all Abbott Affilities worldwide for communicating with their customers.
Quantity in commerce: 17,850
Distribution: Worldwide
Product codes and lots: Lot Number: 07A83-01, 07A083-03, 07A83-95, 07A83-98; All serial numbers

Product code JJE

K974651Class IAbbott Axsym SystemAbbott Laboratories / cleared 1998-02-12

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)