Siemens Healthcare Diagnostics, Inc recalls ADVIA Centaur¿ PSA Assay; Cat No. 06574155/SMN 10310292 (100 test)/02676506/SMN 10310293 (500 test)

Recall date

August 9, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2742-2016

FDA classification

Class II

Brand / firm

Siemens Healthcare Diagnostics, Inc

Sold / distributed

Nationwide Albania Algeria Angola Armenia Austria Bahrain Belgium Bulgaria Burkina Faso Croatia Cyprus Czech Republic Denmark Egypt Estonia Finland France Georgia Germany Great Britain Greece Hungary Iceland Iraq Italy Jordan Kazakhstan Latvia Lithuania Luxembourg Macedonia Malta Netherlands Norway…

Why it was recalled

Communication provided to emphasize that the PSA values should be interpreted in accordance with current clinical guidelines for defining biochemical recurrence following radical prostatectomy.

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

What was recalled

ADVIA Centaur¿ PSA Assay; Cat No. 06574155/SMN 10310292 (100 test)/02676506/SMN 10310293 (500 test)