PlainRecalls
FDA Devices Moderate Class II Terminated

Siemens Acute Care" MYO TestPak-in vitro diagnostic test for the quantitative measurement of myoglobin in heparinized plasma Catalog Number: CMYO SMN:10445079

Reported: January 13, 2016 Initiated: November 11, 2015 #Z-0612-2016

Product Description

Siemens Acute Care" MYO TestPak-in vitro diagnostic test for the quantitative measurement of myoglobin in heparinized plasma Catalog Number: CMYO SMN:10445079

Reason for Recall

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

Details

Units Affected
608
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" MYO TestPak-in vitro diagnostic test for the quantitative measurement of myoglobin in heparinized plasma Catalog Number: CMYO SMN:10445079. Recalled by Siemens Healthcare Diagnostics Inc. Units affected: 608.
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-0612-2016.