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Terminated

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

FDA Recall Z-0117-2007 · Posted 2006-11-17

Recalling FirmAbbott Diagnostic International, Ltd.
Recall StatusTerminated
Product CodeJJE
Date Initiated2006-09-08
Date Terminated2012-01-24
Product Quantity2,355 boxes of 100

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

Other

Distribution Pattern

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

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K041811ABBOTT AXSYM TROPONIN-I ADVAbbott Laboratories · 2004-09-10K974651ABBOTT AXSYM SYSTEMAbbott Laboratories · 1998-02-12

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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