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

Recall Z-0328-2023 — Thermo SCIENTIFIC, Sensititre GN6F, Gram Negative IVD AST

U.S. FDA — Device Enforcement · United States · 2022-10-20 · Class I

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0328-2023
Date of alert
2022-10-20
Country / jurisdiction
United States
Risk level
Class I
Risk type
recall
Brand
Remel Inc
Product category
device
Product type
Devices
Reported risk: An internal technical investigation has confirmed that Thermo Scientific" Gram Negative IVD AST Sensititre Plate may lead to false susceptible results for Proteae Tribe (including Proteus spp., Providencia spp., Morganella Morganii) when tested with doripenem, ertapenem, meropenem, imipenem, cefepime, piperacillin/tazobactam and aztreonam.
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.