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

Recall Z-0027-2018 — Panther(R) System, Catalog Number 902615, For Use with Hologic Assays, For In Vitro Diagnostic Use

U.S. FDA — Device Enforcement · United States · 2017-09-15 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0027-2018
Date of alert
2017-09-15
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Hologic, Inc
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
20900001124
Reported risk: An incorrect incubator was installed on one Panther System which potentially led to incorrect Aptima Combo 2(R) assay (AC2) results.
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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