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Recall Observatory FDA recall evidence

Device product

Siemens Acute Care CKMB DilPak- an in vitro diagnostic product intended to be used in conjunction with the Acute Care CKMB TestPak Catalog Number: CCKMB-D SMN: 10445070

Z-0619-2016

November 11, 2015

Class II

Product summary

Firm
Siemens Healthcare Diagnostics Inc
Event
Event 72570
Status
Terminated
Classification
Class II
Quantity
146
Official record key
device-enforcement:Z-0619-2016

Official wording

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

Code information: Lot Numbers: 845173002

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