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Terminated

Roche brand Elecsys Troponin T; catalog number 2017644.

FDA Recall Z-0512-06 · Posted 2006-02-09

Recalling FirmRoche Diagnostics Corp.
Recall StatusTerminated
Product CodeMMI
Date Initiated2006-01-31
Date Terminated2006-04-10
Product Quantity3116 kits

Reason for Recall

A false negative result may be reported.

Firm Action

Recall letter dated 1/31/06 was issued to each customer instructing them to stop using, and to discard, the product.

Root Cause

Other

Distribution Pattern

Nationwide.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K051752ROCHE ELECSYS TROPONIN T STAT (SHORT TURNAROUND TIME)Roche Diagnostics · 2005-07-11K040733ELECSYS TROPONIN T STAT TESTRoche Diagnostics Corp. · 2004-05-17K984105ELECSYS TROPONIN T STAT TESTBoehringer Mannheim Corp. · 1998-12-08

Official Source

View FDA Recall →

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

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