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Terminated

Stratus CS Acute Care Troponin I TestPak ( Troponin I assay)

FDA Recall Z-2400-2010 · Posted 2010-09-11

Recalling FirmSiemens Healthcare Diagnostics, Inc.
Recall StatusTerminated
Product CodeMMI
Date Initiated2010-04-13
Date Terminated2010-10-25
Product Quantity7500 cartons

Reason for Recall

False elevated Stratus CS CTNI results

Firm Action

Recalling firm issued " Urgent Field Safety Notice" dated April 2010, informing users of the problem and to discuss with laboratory directors regarding the need to review previous test results, conduct patient follow up, and/or repeat testing for tests conducted on or after Nov 1, 2009.

Root Cause

Process control

Distribution Pattern

Nationwide Distribution

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K051650STRATUS CS ACUTE CARE MB ISOENZYME OF CREATINE KINASE (CKMB) TEST PAK; STRATUS CS ACUTE CARE CKMB TESTPAK.Dade Behring, Inc. · 2005-09-08

Official Source

View FDA Recall →

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

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