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
Reported: January 13, 2016 Initiated: November 11, 2015 #Z-0619-2016
Product Description
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
Reason for Recall
Stratus CS Cartridge Barcode labels may not scan on the Stratus CS systems
Details
- Recalling Firm
- Siemens Healthcare Diagnostics Inc
- Units Affected
- 146
- Distribution
- 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.
- Location
- Norwood, MA
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Siemens Healthcare Diagnostics Inc. Units affected: 146.
Why was this product recalled? ▼
Stratus CS Cartridge Barcode labels may not scan on the Stratus CS systems
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on January 13, 2016. Severity: Moderate. Recall number: Z-0619-2016.
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