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

Recall Z-0350-2020 — Universal Sexual Health Testing Kit

U.S. FDA — Device Enforcement · Ireland · 2019-07-01 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0350-2020
Date of alert
2019-07-01
Country / jurisdiction
Ireland
Risk level
Class II
Risk type
recall
Brand
Privapath Diagnostics Ltd
Product category
device
Product type
Devices
Reported risk: A supplier informed PrivaPath Diagnostics that there is a potential for damaged tubes which could result in blood exposure or erroneous results due to an inappropriate blood-to-additive ratio.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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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.