Medical device recalls Moderate risk

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

Recall date
November 11, 2015
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0618-2016
FDA classification
Class II
Brand / firm
Siemens Healthcare Diagnostics Inc
Sold / distributed
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,…

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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

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