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

Recall Z-1230-2015 — ADVIA Centaur Systems Progesterone Kit, (5 -pack); In Vitro Diagnostic; Catalog number: 01586287; SMN:10315522.

U.S. FDA — Device Enforcement · United States · 2015-01-27 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1230-2015
Date of alert
2015-01-27
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)
42565268
Reported risk: ADVIA Centaur Systems Progesterone Kit Lots Ending in 268 have a high bias on results greater than 30 ng/mL (95.4 nmol/L)
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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