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

Recall Z-1991-2014 — ADVIA Centaur¿ Systems TnI-Ultra assay; Catalog Number 02789602 (100 tests), SMN 10317708 and 02790309 (500 tests), SMN 10317790

U.S. FDA — Device Enforcement · United States · 2014-05-30 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1991-2014
Date of alert
2014-05-30
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)
02789602
Reported risk: The solid phase reagent in some of the ADVIA Centaur¿ TnI -Ultra ReadyPacks¿, lot 084, is darker in appearance, creating a potential for incorrect control and patient results.
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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ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.