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

Recall Z-0516-2014 — HemosIL High Abnormal Control 3 UNASSAYED Part Number: 0020003320

U.S. FDA — Device Enforcement · United States · 2013-11-15 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0516-2014
Date of alert
2013-11-15
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Instrumentation Laboratory Co.
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
0020003320
Reported risk: HemosIL Low, Abnormal, Normal Controls UNASSAYED (no-value assigned) lacks 510(k) approval
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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