Skip to content
Recall Observatory FDA recall evidence

Device product

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

Z-0609-2016

November 11, 2015

Class II

Product summary

Firm
Siemens Healthcare Diagnostics Inc
Event
Event 72570
Status
Terminated
Classification
Class II
Quantity
5558
Official record key
device-enforcement:Z-0609-2016

Official wording

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

Code information: Lot Numbers: 235151002, 235159002, 235166002, 235173002, 235208002 235215002, 235222002, 235229002, 235236002, 235243002 235250002, 235257002, 235278002, 235285002

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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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