Home / Recalls / Abbott Molecular, Inc. / Z-1518-2022

Z-1518-2022 Class II

Recalled by Abbott Molecular, Inc. — Des Plaines, IL

Recall Details

Product Type
Devices
Report Date
August 24, 2022
Initiation Date
July 19, 2022
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
1

Product Description

The Alinity m System, REF 08N53-002, For In Vitro Diagnostic Use.

Reason for Recall

Incorrect optical calibration

Distribution Pattern

There was only foreign distribution to Italy.

Code Information

Serial Number 00654

Other recalls by Abbott Molecular, Inc.

  • Z-1749-2025 Class II — Alinity m Resp-4-Plex AMP Kit, List Number 09N79-096, a multiplex real-time reve (April 28, 2025)
  • Z-1748-2025 Class II — Alinity m Resp-4-Plex Amplification (AMP) Kit (CE), List Number 09N79-090, a mul (April 28, 2025)
  • Z-1665-2025 Class II — The Alinity m System is designed to automate the steps for nucleic acid testing. (March 20, 2025)
  • Z-0233-2025 Class II — Abbott Alinity m HPV AMP Kit, used with the Alinity m System, product codes: a) (September 12, 2024)
  • Z-0234-2025 Class II — Abbott Alinity m STI AMP Kit, used with the Alinity m System, product codes: a) (September 12, 2024)
  • Z-1602-2024 Class II — Alinity m System, Part Number: 08N53-002 (March 20, 2024)
  • Z-1190-2024 Class III — Wash station: M1000 Wash Station Assembly & DITI Slide, REF 04J72-28* (*This pa (February 1, 2024)
  • Z-1189-2024 Class III — In-vitro diagnostic kits: (1) Abbott Vysis LSI ATM (11q22.3) SpectrmOrange Pr (February 1, 2024)
  • Z-1188-2024 Class III — In-vitro diagnostic kits: (1) Abbott Vysis MDM2 / CEP 12 FISH Probe Kit, REF (February 1, 2024)
  • Z-0407-2024 Class II — Alinity m HCV AMP kit, List (REF) Numbers: a) 08N50-095 and b) 08N50-090. The A (October 30, 2023)