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Terminated

AxSYM Troponin-I Reagent Kit, list 3C29-20, 100 test kit; Abbott Laboratories, Abbott Park, IL 60064

FDA Recall Z-0782-04 · Posted 2004-07-20

Recalling FirmAbbott Laboratories HPD/ADD/GPRD
Recall StatusTerminated
Product CodeMMI
Date Initiated2004-03-26
Date Terminated2004-10-14
Product Quantity7,394 kits

Reason for Recall

An increase in complaints of higher than normal patient results, some from the healthy population range to above the diagnostic cutoff for an Acute Myocardial Infarction.

Firm Action

Recalled by telephone calls on 3/26/04 and a follow-up letter dated 3/25/04. The accounts were informed of the elevated patient results for the Troponin-I Reagent lots, and were requested to discontinue use and destroy any of the four affected lots found in inventory.

Root Cause

Other

Distribution Pattern

Nationwide and internationally to Abbott affiliates in Argentina, Canada, Germany, Singapore, Hong Kong, Taiwan, Australia, New Zealand, Thailand, China and Korea.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K974103ABBOTT AXSYM TROPONIN-IAbbott Laboratories · 1997-11-25

Official Source

View FDA Recall →

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

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