Abbott Molecular, Inc.

Alinity m HCV

Abbott Molecular, Inc.

Alinity m EBV (09N43-095)

Abbott Molecular, Inc.

Alinity m CMV

Abbott Molecular, Inc.

Alinity m Resp-4-Plex AMP Kit, List Number 09N79-096, a multiplex real-time reverse transcription (RT) polymerase chain

Abbott Molecular, Inc.

Alinity m Resp-4-Plex Amplification (AMP) Kit (CE), List Number 09N79-090, a multiplex real-time reverse transcription (

Abbott Molecular, Inc.

The Alinity m System is designed to automate the steps for nucleic acid testing. Model Numbers included in this recall a

Abbott Molecular, Inc.

Alinity m BKV

Abbott Molecular, Inc.

Alinity m Resp-4-Plex

Abbott Molecular, Inc.

Abbott Alinity m HPV AMP Kit, used with the Alinity m System, product codes: a) REF 09N15-095; b) REF 09N15-090; c) REF

Abbott Molecular, Inc.

Abbott Alinity m STI AMP Kit, used with the Alinity m System, product codes: a) REF 09N17-095; b) REF 09N17-090; c) REF

Abbott Molecular, Inc.

Alinity m HSV 1 & 2 / VZV

Abbott Molecular, Inc.

Alinity m System, Part Number: 08N53-002

Abbott Molecular, Inc.

Wash station: M1000 Wash Station Assembly & DITI Slide, REF 04J72-28* (*This part number is a spare to the M2000sp.)

Abbott Molecular, Inc.

In-vitro diagnostic kits: (1) Abbott Vysis MDM2 / CEP 12 FISH Probe Kit, REF 01N15-010; (2) Abbott Vysis LSI D13S319

Abbott Molecular, Inc.

In-vitro diagnostic kits: (1) Abbott Vysis LSI ATM (11q22.3) SpectrmOrange Probe, REF 01N33-020; (2) Abbott Vysis PT

Abbott Molecular, Inc.

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

Abbott Molecular, Inc.

Abbott Alinity m System, REF 08N53-002, containing Amplification Detetction Unit (ADU) #4.

Abbott Molecular, Inc.

Alinity m STI Assay

Abbott Molecular, Inc.

Alinity m System. The Alinity m System is designed to automate the steps for nucleic acid testing, which includes s

Abbott Molecular, Inc.

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

Abbott Molecular, Inc.

Abbott Alinity m Resp-4-Plex Amp Kit, Part Number 09N79-090

Abbott Molecular, Inc.

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

Abbott Molecular, Inc.

Abbott Alinity m SARS-CoV-2 CTRL Kit, REF 09N78-085, each kit contains 12 x 1.3mL CTRL - and 12 x 1.3 mL CTRL +, For In

Abbott Molecular, Inc.

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

Abbott Molecular, Inc.

Alinity m EBV AMP Kit (List No. 09N43-095), Alinity m EBV CTRL Kit (List No. 09N43-085), Alinity m EBV CAL Kit (List No.

Abbott Molecular, Inc.

Alinity m STI Assay

Abbott Molecular, Inc.

Alinity m HBV AMP Kit (US and CE)

Abbott Molecular, Inc.

Alinity m HBV Application Specification File (US and CE)

Abbott Molecular, Inc.

Alinity m Integrated Reaction Units (IRU)

Abbott Molecular, Inc.

Alinity m System, Part No. 08N53-002

Abbott Molecular, Inc.

Alinity m System, Part No. 08N53-002

Abbott Molecular, Inc.

Alinity m System, Part No. 08N53-002

Abbott Molecular, Inc.

Alinity m System, Part No. 08N53-002

Abbott Molecular, Inc.

Alinity m SARS-CoV-2 Amp Kit (Non-US Assay) and Alinity m SARS-CoV-2 Application Specification File. in vitro diagnostic

Abbott Molecular, Inc.

Alinity m Resp-4-Plex AMP Kit (Non-US Assay) and Alinity m Resp-4-Plex Application Specification File. in vitro diagnost

Abbott Molecular, Inc.

Alinity m SARS-CoV-2 Amp Kit (Emergency Use Authorization, US Assay) and Alinity m SARS-CoV-2 Application Specification

Abbott Molecular, Inc.

Alinity m SARS-CoV-2 Amp Kit (Non-US Assay) and Alinity m SARS-CoV-2 Application Specification File. in vitro diagnostic

Abbott Molecular, Inc.

Alinity m Resp-4-Plex AMP Kit (Emergency Use Authorization, US Assay) and Alinity m Resp-4-Plex Application Specificatio

Abbott Molecular, Inc.

Vysis CLL FISH Probe Kit with the following components: Vysis LSI p53 SpectrumOrange/ATM, SpectrumGreen and LSI D13S319,

Abbott Molecular, Inc.