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

Recall Z-0877-2022 — Panther Fusion GBS Assay Cartridges 96 Tests, Catalog Number: PRD-04484. in vitro diagnostic test for group b streptococcus.

U.S. FDA — Device Enforcement · United States · 2022-03-18 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0877-2022
Date of alert
2022-03-18
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Hologic, Inc
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
15420045510890
Reported risk: Samples, run on a GBS Assay, that have analyte concentrations that are at or near the limit of detection may produce false negative results.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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