FDA recall record · openFDA

Abbott Molecular, Inc.

10 FDA recalls on record (2023–2025) — 10 device. 10 still ongoing.

Class I (most serious)

Class II

Class III

ongoing

How to read this. A recall count is not a quality verdict — large manufacturers recall more simply by volume, and a voluntary recall is the safety system working as intended. The signal to weight is the Class I count (the FDA's most-serious tier — reasonable probability of serious harm or death) and whether recalls are still ongoing. Most recalls are Class II/III. "Ongoing" reflects openFDA's last-published status — device recalls often stay marked ongoing long after they're resolved in practice; confirm current status at the FDA.

Most common reasons

Products that were intended for export only which were not approved or registered in accordance with U.S. specifications 3

Abbott has identified an increase of incidences regarding Error Code (EC) 9198 (Positive control is non-reactive) while 2

There were reports of an increase in reactive negative controls and false positive results. 2

The design of the Alinity m System Solutions drawer enclosure may allow liquid (liquid waste or system solutions) origin 1

The Alinity m System camera detects whether tubes are "capped." If the camera detects a cap and the retention bar is not 1

Recalls

The Alinity m System is designed to automate the steps for nucleic acid testing. Model Numbers included in this recall a Class II 2025-03-20 Alinity m Resp-4-Plex AMP Kit, List Number 09N79-096, a multiplex real-time reverse transcription (RT) polymerase chain Class II 2025-04-28 Alinity m Resp-4-Plex Amplification (AMP) Kit (CE), List Number 09N79-090, a multiplex real-time reverse transcription ( Class II 2025-04-28 Abbott Alinity m HPV AMP Kit, used with the Alinity m System, product codes: a) REF 09N15-095; b) REF 09N15-090; c) REF Class II 2024-09-12 Abbott Alinity m STI AMP Kit, used with the Alinity m System, product codes: a) REF 09N17-095; b) REF 09N17-090; c) REF Class II 2024-09-12 Alinity m System, Part Number: 08N53-002 Class II 2024-03-20 Alinity m HCV AMP kit, List (REF) Numbers: a) 08N50-095 and b) 08N50-090. The Alinity m HCV assay is an in vitro revers Class II 2023-10-30 Wash station: M1000 Wash Station Assembly & DITI Slide, REF 04J72-28* (*This part number is a spare to the M2000sp.) Class III 2024-02-01 In-vitro diagnostic kits: (1) Abbott Vysis MDM2 / CEP 12 FISH Probe Kit, REF 01N15-010; (2) Abbott Vysis LSI D13S319 Class III 2024-02-01 In-vitro diagnostic kits: (1) Abbott Vysis LSI ATM (11q22.3) SpectrmOrange Probe, REF 01N33-020; (2) Abbott Vysis PT Class III 2024-02-01

RECORDED — these are the FDA's published recall enforcement records (openFDA). Recalls are listed under the exact firm name as filed; a large manufacturer may also file under name variants, so this may not be the company's complete cross-variant record — confirm at the FDA recall database. This page informs and routes; it is not medical advice or a verdict on the company.

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