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

Recall Z-1328-2015 — Ebola IgX VP-40 Serum/Plasma/Blood Cassette, Catalog No. I-100 Materials Provided: 1. Test Device 2. Lancet 3. Alcohol pad. 4. Develop buffer tube contain buffer vial (0.3ml)

U.S. FDA — Device Enforcement · United States · 2015-03-13 · Class I

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1328-2015
Date of alert
2015-03-13
Country / jurisdiction
United States
Risk level
Class I
Risk type
recall
Brand
Lusys Laboratories, Inc.
Product category
device
Product type
Devices
Reported risk: LuSys Laboratories is recalling Ebola Virus One Step Test Kits to stop and prevent further use of these devices. The Ebola Virus One-Step Test Kits have not yet been cleared, approved or authorized by the FDA for diagnostics purposes.
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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