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Recall Observatory FDA recall evidence

Device product

Siemens Acute Care MYO DilPak Catalog Number: CMYO-D SMN:10445081 in vitro diagnostic

Z-0618-2016

November 11, 2015

Class II

Product summary

Firm
Siemens Healthcare Diagnostics Inc
Event
Event 72570
Status
Terminated
Classification
Class II
Quantity
192
Official record key
device-enforcement:Z-0618-2016

Official wording

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

Code information: Lot Numbers: 815131002, 815222002

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