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Terminated

Stratus CS Acute Care Troponin I TestPak, Catalog number CCTNI, in vitro diagnostic.

FDA Recall Z-0668-2009 · Posted 2009-01-28

Recalling FirmDade Behring, Inc.
Recall StatusTerminated
Product CodeJHX
Date Initiated2008-06-23
Date Terminated2009-01-29
Product Quantity5868 cartons

Reason for Recall

Incorrect result: Potential for false elevation of CTnI results

Firm Action

Siemens issued an Urgent Field Safety Notice dated 6/23/08 with instructions to immediately discontinue use and discard the affected lots. Customers were also instructed to contact Siemens Customer Service Center at 800-241-0420 to request replacement product at no charge.

Root Cause

Nonconforming Material/Component

Distribution Pattern

Worldwide distribution: USA, Singapore, Saudi Arabia, Japan, Germany, Canada, Bahrain, Australia, Korea, and India.

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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