Z-0173-04

AxSYM Analyzer, Small Heater Block Clamp, manufactured by Abbott Laboratories, Irving, Texas

Name: Z-0173-04 AxSYM Analyzer, Small Heater Block Clamp, manufactured by Abbott Laboratories, Irving, Texas
Creator: Abbott Laboratories, Inc
Published: 2002-06-06
License: https://open.fda.gov/license/

Abbott Medical / initiated 2002-06-06 / Terminated

FDA source

Abbott Laboratories, Inc began a recall of AxSYM Analyzer, Small Heater Block Clamp, manufactured by Abbott Laboratories, Irving, Texas on 2002-06-06. The reason FDA records is "Clamp can cause misaligned seating of heater block resulting in inaccurate dispension of MEIA Wash Buffer or MUP into the reaction cell. Causes inconsistent results". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0173-04
Status: Terminated
Initiated: 2002-06-06
Posted: 2004-07-20
Terminated: 2004-08-09
Recalling firm: Abbott Medical
Product: AxSYM Analyzer, Small Heater Block Clamp, manufactured by Abbott Laboratories, Irving, Texas
Product code: JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Reason for recall: Clamp can cause misaligned seating of heater block resulting in inaccurate dispension of MEIA Wash Buffer or MUP into the reaction cell. Causes inconsistent results.
FDA root cause: Other
Action: All consignees received Technical Service Bulletin (TSB) #83-081. This TSB gave instructions on how to install the AxSYM Small Heater Block clamp upgrade implemented June 6, 2002.
Quantity in commerce: 15437 units worldwide
Distribution: Nationwide and to the following foreign locations: Mexico, Viet Nam, Venezuela, Columbia, Argentina, Chile, Japan, Austria, Denmark, France, Israel, Norway, Saudi Arabia, Spain, Turkey, India, Phillippines, Brazil, Puerto Rico, Dominicam Republic, Canada, Germany, Taiwan, Thailand, Belgium, Egypt, Greece, Italy, Poland, South Africa, Sweden, United Arab Emirates, Malaysia, Singapore, Hong Kong, Australia, New Zealand, China, Uruguay, Korea, England, Czech Republic, Finland, Hungary, Netherlands, Portugal, Eastern Europe, Switzerland, Central America, and Pakistan
Product codes and lots: 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)