Siemens Healthcare Diagnostics, Inc recalls ADVIA Centaur CA 125II Assay; Cat No. 09427226, SMN 10310443 (1-pack/100 tests); Cat no. 01678114, SMN 10315696 (5-pack…

Recall date: February 21, 2018
Source: U.S. Food & Drug Administration (FDA) — enforcement report
Recall number: Z-1486-2018
FDA classification: Class II
Brand / firm: Siemens Healthcare Diagnostics, Inc
Sold / distributed: US Nationwide, and the following countries: Albania, Angola, Argentina, Armenia, Australia, Austria, Bahrain, Bangladesh, Belgium, Bosnia Herzegovina, Brazil, Bulgaria, Cambodia, Canada, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Ecuador, Egypt, Estonia, Finland,…

Why it was recalled

Upon dilution, some patient samples may exhibit over-recovery outside the representative data provided in the assay instructions for use.

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

ADVIA Centaur CA 125II Assay; Cat No. 09427226, SMN 10310443 (1-pack/100 tests); Cat no. 01678114, SMN 10315696 (5-pack/500 tests)

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