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

Recall Z-0655-2021 — Viral Transport Medium, 3ml, Ref: R99, Container type: Tube, Packaged: 20 tubes/box, IVD, CVM Transport Media is provided in plastic centrifuge tubes and is used for the collection and transport of clinical specimens for the recovery of viral agents

U.S. FDA — Device Enforcement · United States · 2020-10-23 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0655-2021
Date of alert
2020-10-23
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Hardy Diagnostics
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
819398023818
Reported risk: There is a potential for contamination within Viral Transport Media. Use of contaminated Viral Transport Media for the transport of patient specimen may compromise the detection of COVID-19 by the final device used for testing.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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