Z-0421-03

AxSYM System, Lift Mechanisms: List Numbers 7A83-01, 7A83-95, 7A83-98, and 7A83-03

Name: Z-0421-03 AxSYM System, Lift Mechanisms: List Numbers 7A83-01, 7A83-95, 7A83-98, and 7A83-03
Creator: Abbott Laboratories, Inc
Published: 2002-12-18
License: https://open.fda.gov/license/

Abbott Medical / initiated 2002-12-18 / Terminated

FDA source

Abbott Laboratories, Inc began a recall of AxSYM System, Lift Mechanisms: List Numbers 7A83-01, 7A83-95, 7A83-98, and 7A83-03 on 2002-12-18. The reason FDA records is "Gas Springs supporting processing center cover lose pressure after repeated usage causing the cover to unexpectedly close". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0421-03
Status: Terminated
Initiated: 2002-12-18
Posted: 2003-01-11
Terminated: 2004-04-07
Recalling firm: Abbott Medical
Product: AxSYM System, Lift Mechanisms: List Numbers 7A83-01, 7A83-95, 7A83-98, and 7A83-03
Product code: JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Reason for recall: Gas Springs supporting processing center cover lose pressure after repeated usage causing the cover to unexpectedly close.
FDA root cause: Other
Action: Abbott Laboratories sent a December 18, 2002 letter to all consignees informing consignees of their plans to install a locking mechanism on all AxSYM Systems. The installations will be performed by Abbott Representatives. A customer reply form was included in the device correction letter.
Quantity in commerce: 18,832 units
Distribution: Nationwide and to the following foreign countries: Mexico, Guatemala, Venezuela, Columbia, Ecuador, Peru, Chile, Uruguay, Argentina, Brazil, Dominican Republic, El Salvador, Canada, Germany, Ireland, England, Belgium, France, Austria, Italy, Spain, Russia, Japan, Singapore, Hong Kong, Taiwan, Thailand, Malaysia, Korea, Australia, New Zeland, Honduras, Costa Rica, Trinidad, Bahamas, Northern Antilles, Bermuda, Panama, West Indies, Paraguay, Norway, Kingstow, VC
Product codes and lots: List Numbers: 7A83-01, 7A83-95, 7A83-98, and 7A83-03

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)