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

Recall Z-1665-2025 — The Alinity m System is designed to automate the steps for nucleic acid testing. Model Numbers included in this recall are 08N53-001, 08N53-002, and 08N53-032 (Refurbished).

U.S. FDA — Device Enforcement · United States · 2025-03-20 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1665-2025
Date of alert: 2025-03-20
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Abbott Molecular, Inc.
Product category: device
Product type: Devices
Barcode (EAN/GTIN): 00884999047389

Reported risk: The design of the Alinity m System Solutions drawer enclosure may allow liquid (liquid waste or system solutions) originating in the System Solutions drawer to flow beyond the footprint of the instrument and into the walking-path of the user.

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.

Recall Z-1665-2025 — The Alinity m System is designed to automate the steps for nucleic acid testing. Model Numbers included in this recall are 08N53-001, 08N53-002, and 08N53-032 (Refurbished).

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