Abbott Molecular, Inc.
Complete recall history across all FDA and CPSC categories — 30 total recalls
Abbott Molecular, Inc. appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.
Device Recalls (30)
FDA medical device enforcement actions by Abbott Molecular, Inc.
| Date | Product | Reason | Class |
|---|---|---|---|
| Apr 28, 2025 | Alinity m Resp-4-Plex Amplification (AMP) Kit (CE), List Number 09N79-090, a ... | There were reports of an increase in reactive negative controls and false pos... | Class II |
| Apr 28, 2025 | Alinity m Resp-4-Plex AMP Kit, List Number 09N79-096, a multiplex real-time r... | There were reports of an increase in reactive negative controls and false pos... | Class II |
| Mar 20, 2025 | The Alinity m System is designed to automate the steps for nucleic acid testi... | The design of the Alinity m System Solutions drawer enclosure may allow liqui... | Class II |
| Sep 12, 2024 | Abbott Alinity m STI AMP Kit, used with the Alinity m System, product codes: ... | Abbott has identified an increase of incidences regarding Error Code (EC) 919... | Class II |
| Sep 12, 2024 | Abbott Alinity m HPV AMP Kit, used with the Alinity m System, product codes: ... | Abbott has identified an increase of incidences regarding Error Code (EC) 919... | Class II |
| Mar 20, 2024 | Alinity m System, Part Number: 08N53-002 | The Alinity m System camera detects whether tubes are "capped." If the camera... | Class II |
| Feb 1, 2024 | In-vitro diagnostic kits: (1) Abbott Vysis LSI ATM (11q22.3) SpectrmOrange... | Products that were intended for export only which were not approved or regist... | Class III |
| Feb 1, 2024 | In-vitro diagnostic kits: (1) Abbott Vysis MDM2 / CEP 12 FISH Probe Kit, R... | Products that were intended for export only which were not approved or regist... | Class III |
| Feb 1, 2024 | Wash station: M1000 Wash Station Assembly & DITI Slide, REF 04J72-28* (*This... | Products that were intended for export only which were not approved or regist... | Class III |
| Oct 30, 2023 | Alinity m HCV AMP kit, List (REF) Numbers: a) 08N50-095 and b) 08N50-090. Th... | Abbott has received reports of an increase in reactive negative controls and ... | Class II |
| Dec 9, 2022 | Alinity m System. The Alinity m System is designed to automate the steps... | The firm identified the following three potential issues which may have impac... | Class II |
| Nov 22, 2022 | Abbott Alinity m Resp-4-Plex Amp Kit, Part Number 09N79-090 | Reports of an increase in reactive negative controls and false positive resul... | Class II |
| Nov 22, 2022 | Abbott Alinity m Resp-4-Plex Amp Kit, Part Number 09N79-096 | Reports of an increase in reactive negative controls and false positive resul... | Class II |
| Nov 11, 2022 | Abbott Alinity m System, REF 08N53-002, containing Amplification Detetction U... | The instrument was found to be installed without plunger assemblies in the cl... | Class II |
| Oct 12, 2022 | Alinity m System, REF 08N53-002, For In Vitro Diagnostic Use | Abbott has identified potential performance issues for the Alinity m System s... | Class II |
| Aug 19, 2022 | Abbott Alinity m SARS-CoV-2 CTRL Kit, REF 09N78-085, each kit contains 12 x 1... | Reports received of an increase of message code 9186 (internal control failed... | Class II |
| Jul 19, 2022 | The Alinity m System, REF 08N53-002, For In Vitro Diagnostic Use. | Incorrect optical calibration | Class II |
| Mar 4, 2022 | Alinity m HBV Application Specification File (US and CE) | There is a potential for misquantitation high results of negative samples. | Class II |
| Mar 4, 2022 | Alinity m HBV AMP Kit (US and CE) | There is a potential for misquantitation high results for negative samples. | Class II |
| Feb 11, 2022 | Alinity m Integrated Reaction Units (IRU) | There is potential for the Reaction Vessels (RVs) detaching from the RV cap d... | Class II |
| Dec 6, 2021 | Alinity m System, Part No. 08N53-002 | There is an issue with the installation of updated camera firmware on the sys... | Class II |
| Dec 6, 2021 | Alinity m System, Part No. 08N53-002 | There is a software defect that can cause the Amplification Detection clamp C... | Class II |
| Dec 6, 2021 | Alinity m System, Part No. 08N53-002 | There is a software issue associated with the ability to properly complete a ... | Class II |
| Dec 6, 2021 | Alinity m System, Part No. 08N53-002 | There is a potential for abnormal (non-sigmoidal) amplification curves. | Class II |
| Sep 2, 2021 | Alinity m Resp-4-Plex AMP Kit (Emergency Use Authorization, US Assay) and Ali... | There is a potential for false positive results. | Class I |
| Sep 2, 2021 | Alinity m SARS-CoV-2 Amp Kit (Non-US Assay) and Alinity m SARS-CoV-2 Applicat... | There is a potential for false positive results. | Class I |
| Sep 2, 2021 | Alinity m SARS-CoV-2 Amp Kit (Emergency Use Authorization, US Assay) and Alin... | There is a potential for false positive results. | Class I |
| Sep 2, 2021 | Alinity m Resp-4-Plex AMP Kit (Non-US Assay) and Alinity m Resp-4-Plex Applic... | There is a potential for false positive results. | Class I |
| Sep 2, 2021 | Alinity m SARS-CoV-2 Amp Kit (Non-US Assay) and Alinity m SARS-CoV-2 Applicat... | There is a potential for false positive results. | Class I |
| Aug 4, 2021 | Vysis CLL FISH Probe Kit with the following components: Vysis LSI p53 Spectru... | Potential for Vysis CLL FISH Probe Kits not detecting 13q deletions in known ... | Class II |
Frequently Asked Questions
A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.
Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.
The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.
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