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

Recall Z-1486-2018 — ADVIA Centaur CA 125II Assay; Cat No. 09427226, SMN 10310443 (1-pack/100 tests); Cat no. 01678114, SMN 10315696 (5-pack/500 tests)

U.S. FDA — Device Enforcement · United States · 2018-02-21 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1486-2018
Date of alert
2018-02-21
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)
10310443
Reported risk: Upon dilution, some patient samples may exhibit over-recovery outside the representative data provided in the assay instructions for use.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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