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

Recall Z-1580-2016 — Hologic InPlex CF Molecular Test (IVD); Catalog Number: 95-432.

U.S. FDA — Device Enforcement · United States · 2016-03-31 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1580-2016
Date of alert
2016-03-31
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Hologic, Inc
Product category
device
Product type
Devices
Reported risk: Complaints of false positive HET mutations and leaking cards; could lead to unnecessary invasive testing during pregnancy and the associated risks of such invasive testing.
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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