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Terminated

ARCHITECT STAT Troponin-I Reagent Kit, list 2K41-20; each 400 test kit contains 4 bottles each of microparticles, conjugate and assay diluent; Abbott Laboratories, Abbott Park, IL 60064

FDA Recall Z-0513-06 · Posted 2006-02-14

Recalling FirmAbbott Laboratories MPG
Recall StatusTerminated
Product CodeMMI
Date Initiated2005-12-21
Date Terminated2006-07-31
Product Quantity181 kits

Reason for Recall

There has been an increase in customer complaints observed for failure to calibrate or inability to generate patient result errors.

Firm Action

Abbott sent recall letters dated 12/20/05 to the laboratory accounts via Federal Express Priority on 12/21/05. The accounts were informed of the increase in customer complaints for failure to calibrate or inability to generate patient result errors for the Troponin-I Reagent lot, and were requested to discontinue use and destroy any of the affected lot found in inventory for replacement.

Root Cause

Other

Distribution Pattern

Nationwide and internationally to Canada, Australia, Germany and Taiwan

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K041192ARCHITECT STAT TROPONIN-I IMMUNOASSAYFisher Diagnostics · 2004-08-12

Official Source

View FDA Recall →

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

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