Medical device recalls

Siemens Healthcare Diagnostics, Inc. recalls Syva¿ EMIT¿ II Plus 6-Acetyl morphine Catalog # for 28 mL: 9R039UL /SMN# 10470440

Recall date
March 12, 2018
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1800-2018
FDA classification
Class III
Brand / firm
Siemens Healthcare Diagnostics, Inc.
Sold / distributed
PA, MA, TX, ME, UT, FL, KS, NH, KY and Foreign

Why it was recalled

Incorrect calibrator level listed in qualitative calibration steps

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

Syva¿ EMIT¿ II Plus 6-Acetyl morphine Catalog # for 28 mL: 9R039UL /SMN# 10470440

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