Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-2742-2016 — ADVIA Centaur¿ PSA Assay; Cat No. 06574155/SMN 10310292 (100 test)/02676506/SMN 10310293 (500 test)

U.S. FDA — Device Enforcement · United States · 2016-08-09 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-2742-2016
Date of alert
2016-08-09
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Siemens Healthcare Diagnostics, Inc
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
10310292
Reported risk: Communication provided to emphasize that the PSA values should be interpreted in accordance with current clinical guidelines for defining biochemical recurrence following radical prostatectomy.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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