Home / Recalls / Abbott Molecular, Inc. / Z-0739-2023

Z-0739-2023 Class II Ongoing

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

Recall Details

Product Type
Devices
Report Date
December 28, 2022
Initiation Date
November 22, 2022
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
3896 kits

Product Description

Abbott Alinity m Resp-4-Plex Amp Kit, Part Number 09N79-096

Reason for Recall

Reports of an increase in reactive negative controls and false positive results with certain lots of Alinity M Resp-4-Plex AMP kits.

Distribution Pattern

Worldwide

Code Information

Lot Numbers: 381465, exp 8/24/2023; 524433, exp 1/5/2023; 526710, exp 1/21/2023; 527845, exp 2/8/20231499

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-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-1190-2024 Class III — Wash station: M1000 Wash Station Assembly & DITI Slide, REF 04J72-28* (*This pa (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)