Z-0117-2007

Abbott AxSYM Matrix Cells--Product List No: 8A73-02, sold in boxes of 100

Name: Z-0117-2007 Abbott AxSYM Matrix Cells--Product List No: 8A73-02, sold in boxes of 100
Creator: Abbott Diagnostic International, Ltd.
Published: 2006-09-08
License: https://open.fda.gov/license/

Abbott Diagnostic International, Ltd. / initiated 2006-09-08 / Terminated / root cause: manufacturing process

FDA source

Abbott Diagnostic International, Ltd. began a recall of Abbott AxSYM Matrix Cells--Product List No: 8A73-02, sold in boxes of 100 on 2006-09-08. The reason FDA records is "Increase in complaints regarding controls out of range, calibration errors, and discrepant patient results with the AxSYM Troponin-I ADV assay". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0117-2007
Status: Terminated
Initiated: 2006-09-08
Posted: 2006-11-17
Terminated: 2012-01-24
Recalling firm: Abbott Diagnostic International, Ltd.
Product: Abbott AxSYM Matrix Cells--Product List No: 8A73-02, sold in boxes of 100
Product code: JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Reason for recall: Increase in complaints regarding controls out of range, calibration errors, and discrepant patient results with the AxSYM Troponin-I ADV assay.
Root cause tag: manufacturing process
FDA root cause: Other
Quantity in commerce: 2,355 boxes of 100
Distribution: Nationwide including the states of AL, AK, AZ, CA, CT, CO, DE, FL, GA, ID, IL, IA, IN, KS, KY, LA, MA, ME, MI, MS, MN, MT, MO, NM, NJ, NY, NV, OH, OK, PA, RI, SC, TN, TX, UT, VA, WA, WI, Hawaii and Puerto Rico
Product codes and lots: Lot # 37618Q100 Expiration Date 12/05/2006

Product code JJE

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)