Medical DeviceOct 20, 2021
Abbott Molecular Alinity m SARS-CoV-2 Amp Kit (Non-US Assay) and Alinity m SARS-CoV-2 recall — FDA Z-0006-2022
There is a potential for false positive results.
Class IFDA: TerminatedAbbott Molecular, Inc.
Recall history in this database
Classification mix: Class II: 19, Class I: 5, Class III: 3.
Medical DeviceOct 20, 2021
Abbott Molecular Alinity m Resp-4-Plex AMP Kit recall — FDA Z-0005-2022
There is a potential for false positive results.
Class IFDA: TerminatedAbbott Molecular, Inc.
Medical DeviceOct 6, 2021
Abbott Molecular Vysis CLL FISH Probe Kit with the following components: Vysis LSI p53 recall — FDA Z-2576-2021
Potential for Vysis CLL FISH Probe Kits not detecting 13q deletions in known positive patient samples.
Class IIFDA: TerminatedAbbott Molecular, Inc.
Understanding this recall history
This page summarizes recall records in which the official source identifies Abbott Molecular, Inc. as the recalling firm or manufacturer. The number of records should not be treated as a safety rating or a measure of company size, because recall counts depend on product mix, reporting periods and how government records are organized.
Compare the dates, categories and classifications together rather than relying on the total alone. Open an individual record for the recalled product, reason, distribution details and current instructions available from the source.