59 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Status: Open, Classified
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Brand Name: Alinity hq Analyzer Product Name: Alinity hq Analyzer Model/Catalog Number: 09P68-01 Software Version: 5.0 to 5.10.1 for OUS, 5.7 and 5.10.1 in the US Product Description: Alinity hq Analyzer Component: No
FDA Recall
Open, Classified
·Abbott Laboratories·Product code GKZ·September 18, 2025
Abbott Alinity m HPV AMP Kit, used with the Alinity m System, product codes: a) REF 09N15-095; b) REF 09N15-090; c) REF 09N15-091
FDA Recall
Open, Classified
·Abbott Molecular, Inc.·Product code MAQ·September 12, 2024
Abbott Alinity m STI AMP Kit, used with the Alinity m System, product codes: a) REF 09N17-095; b) REF 09N17-090; c) REF 09N17-091;
FDA Recall
Open, Classified
·Abbott Molecular, Inc.·Product code QEP·September 12, 2024
Abbott Alinity m Resp-4-Plex Amp Kit, Part Number 09N79-096
FDA Recall
Open, Classified
·Abbott Molecular, Inc.·Product code QJR·November 22, 2022
Abbott Alinity m Resp-4-Plex Amp Kit, Part Number 09N79-090
FDA Recall
Open, Classified
·Abbott Molecular, Inc.·Product code QJR·November 22, 2022
Abbott CELL-DYN Ruby, Model CD-Ruby, List number 08H67-01, and Abbott CELL-DYN Sapphire, Model CD Sapphire, list number 08H00-01. Multi-parameter, automated hematology analyzer.
FDA Recall
Open, Classified
·Abbott Laboratories·Product code GKZ·October 19, 2023
Alinity c Iron Reagent, Reference Number 08P3920
FDA Recall
Open, Classified
·Sentinel CH SpA Via Robert Koch·Product code JIY·September 29, 2023
In-vitro diagnostic kits: (1) Abbott Vysis LSI ATM (11q22.3) SpectrmOrange Probe, REF 01N33-020; (2) Abbott Vysis PTEN/CEP 10 FISH Probe Kit, REF 04N62-020; (3) Abbott Vysis TelVysion 1p SpectrumGreen Probe, REF 05J03-001; (4) Abbott Vysis TelVysion 4P SpectrumGreen Probe, REF 05J03-004; (5) Abbott Vysis TelVysion 22q SpectrumOrange Probe, REF 05J04-022;
FDA Recall
Open, Classified
·Abbott Molecular, Inc.·Product code MVU·February 1, 2024
IRON assay, Reference Numbers 6K95-41 and 6K95-30
FDA Recall
Open, Classified
·Sentinel CH SpA Via Robert Koch·Product code JIY·September 29, 2023
ARCHITECT c4000 Processing Module REF: 02P24-01 02P24-02 02P24-40 01R24-56 01R25-56 The Abbott ARCHITECT c4000 Processing Module is designed to perform automated chemistry tests, utilizing photometry and potentiometric technology.
FDA Recall
Open, Classified
·Abbott Laboratories·Product code JJE·October 19, 2023
Alinity m System. The Alinity m System is designed to automate the steps for nucleic acid testing, which includes sample processing, amplification, detection, and data reduction.
FDA Recall
Open, Classified
·Abbott Molecular, Inc.·Product code OOI·December 9, 2022
In-vitro diagnostic kits: (1) Abbott Vysis MDM2 / CEP 12 FISH Probe Kit, REF 01N15-010; (2) Abbott Vysis LSI D13S319 (13q14.3) SpectrumOrange Probe, REF 01N34-020;
FDA Recall
Open, Classified
·Abbott Molecular, Inc.·Product code OYU·February 1, 2024
Alinity m Resp-4-Plex Amplification (AMP) Kit (CE), List Number 09N79-090, a multiplex real-time reverse transcription (RT) polymerase chain reaction (PCR) test intended for the qualitative detection and differentiation of RNA from influenza A virus (flu A), influenza B virus (flu B), Respiratory Syncytial Virus (RSV), and SARS-CoV-2 in nasopharyngeal (NP) swab specimens collected by a healthcare provider, from individuals with signs and symptoms of respiratory tract infection
FDA Recall
Open, Classified
·Abbott Molecular, Inc.·Product code QJR·April 28, 2025
Alinity m Resp-4-Plex AMP Kit, List Number 09N79-096, a multiplex real-time reverse transcription (RT) polymerase chain reaction (PCR) test intended for the simultaneous qualitative detection and differentiation of RNA from SARS-CoV-2, influenza A virus (flu A), influenza B virus (flu B), and/or Respiratory Syncytial Virus (RSV) in anterior nasal or nasopharyngeal swab specimens collected by a healthcare provider (HCP), or in anterior nasal swab specimens that are self-collected at a healthcare location, from individuals suspected by their HCP of respiratory viral infection consistent with COVID-19.
FDA Recall
Open, Classified
·Abbott Molecular, Inc.·Product code QJR·April 28, 2025
Alinity ci Level Sensor, Bulk Solution
FDA Recall
Open, Classified
·Abbott Gmbh & Co. KG Max-Planck-Ring 2 65205 Wiesbaden Germany·Product code JJE·September 16, 2019
Alinity i Processing Module REF 03R65-01 The Alinity i Processing Module is a fully automated immunoassay analyzer allowing random and continuous access, as well as priority and automated retest processing using chemiluminescent microparticle immunoassay (CMIA) technology. CMIA technology is used to determine the presence of antigens, antibodies, and analytes in samples.
FDA Recall
Open, Classified
·Abbott Laboratories·Product code JJE·October 19, 2023
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).
FDA Recall
Open, Classified
·Abbott Molecular, Inc.·Product code OOI·March 20, 2025
ARCHITECT Anti-HCV Reagent Kit, List Numbers: a) 1L79-25, b) 1L79-35
FDA Recall
Open, Classified
·Abbott GmbH Max-Planck-Ring 2 Wiesbaden Germany·Product code MZO·March 4, 2024
Alinity i Anti-HCV Reagent Kit, List Number 08P0521
FDA Recall
Open, Classified
·Abbott GmbH Max-Planck-Ring 2 Wiesbaden Germany·Product code MZO·March 4, 2024
Accessory kit, Alinity i containing Alinity ci Level Sensor, Bulk Solution
FDA Recall
Open, Classified
·Abbott Gmbh & Co. KG Max-Planck-Ring 2 65205 Wiesbaden Germany·Product code JJE·September 16, 2019