Abbott Diagnostic International, Ltd. Carr 2 Km 58.0 Cruce Davila Abbott AxSYM Matrix Cells--Product List No: 8A73-02, sold in boxes of 100 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Abbott AxSYM Matrix Cells--Product List No: 8A73-02, sold in boxes of 100
Brand
Abbott Diagnostic International, Ltd. Carr 2 Km 58.0 Cruce Davila
Lot Codes / Batch Numbers
Lot # 37618Q100 Expiration Date 12/05/2006
Products Sold
Lot # 37618Q100 Expiration Date 12/05/2006
Abbott Diagnostic International, Ltd. Carr 2 Km 58.0 Cruce Davila is recalling Abbott AxSYM Matrix Cells--Product List No: 8A73-02, sold in boxes of 100 due to Increase in complaints regarding controls out of range, calibration errors, and discrepant patient results with the AxSYM Troponin-I ADV assay.. Based on FDA medical device recall database.
Summary derived from FDA notice
The following details were not provided by the FDA: corrective action details.
Reason for Recall
As stated by FDA
Increase in complaints regarding controls out of range, calibration errors, and discrepant patient results with the AxSYM Troponin-I ADV assay.
Recommended Action
Per FDA guidance
Healthcare providers and patients should stop using the device and contact the manufacturer for further instructions. Report problems to FDA MedWatch.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026