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Terminated

Siemens Acute Care CTNI TestPak-in vitro diagnostic test for the measurement of cardiac troponin I in heparinized plasma Catalog Number: CCTNI SMN: 10445071

FDA Recall Z-0609-2016 · Posted 2016-01-07

Recalling FirmSiemens Healthcare Diagnostics Inc
Recall StatusTerminated
Product CodeMMI
Date Initiated2015-11-11
Date Terminated2016-09-23
Product Quantity5558

Reason for Recall

Stratus CS Cartridge Barcode labels may not scan on the Stratus CS systems

Firm Action

Siemens Healthcare Diagnostics issued an Urgent Field Safety Notice by e-mail to all affected Siemens Healthcare Diagnostics Regional offices on November 11, 2015 both in the United States and internationally for communication with affected customers. This notice informs customers of the issue and provides mitigation instructions. Customers with questions were advised to contact their Siemens Customer Care Center or their local Siemens technical support representative. For questions regarding call 781-269-3000.

Root Cause

Labeling design

Distribution Pattern

Worldwide Distribution - US (nationwide), Algeria, Armenia, Australia, Austria, Bangladesh, Bosnia Herzegovina, Canada, Croatia, Czech Republic, Denmark, Finland, France, Germany, Greece, India, Ireland, Italy, Japan, Libya, Malaysia, Poland, Portugal, Romania, Saudi Arabia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Turkey, U.A.E., and United Kingdom.

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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