Abbott Molecular, Inc. recalls The Alinity m System is designed to automate the steps for nucleic acid testing. Model Numbers included in this recall are 08N53-001,…
The design of the Alinity m System Solutions drawer enclosure may allow liquid (liquid waste or system solutions) originating in the System Solutions drawer to flow beyond the footprint of the instrument and into the…
Read the official notice →- Date
- 2025-04-30
- Country
- United States
- Brand
- Abbott Molecular
- Product
- The Alinity m System is designed to automate the steps for nucleic acid testing. Model Numbers included in this recall are 08N53-001,…
- Classification
- Class II
- Units
- Worldwide - US Nationwide distribution.
- Category
- Drugs & medical
- Source
- FDA · Device
Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer
What to do
- Check the product name, strength and lot number against the official notice.
- Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
- Ask the pharmacy or supplier about a replacement or refund.
General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.
More Abbott Molecular recalls
- 2025-05-21
USAbbott Molecular, Inc. recalls Alinity m Resp-4-Plex AMP Kit, List Number 09N79-096, a multiplex real-time reverse transcription (RT) polymerase chain reaction (PCR)…
There were reports of an increase in reactive negative controls and false positive results.
- 2024-11-06
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Abbott Molecular, Inc. recalls 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
Abbott has identified an increase of incidences regarding Error Code (EC) 9198 (Positive control is non-reactive) while using the Alinity m HR HPV AMP Kit and Alinity m STI AMP Kit. Certain invalidated positive assay…
FDA · DeviceAbbott Molecular, Inc.Worldwide distribution: US (nationwide) to states of: AZ, CA, CO, DC, FL, GA,…Official notice → - 2024-05-01
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Abbott Molecular, Inc. recalls Alinity m System, Part Number: 08N53-002
The Alinity m System camera detects whether tubes are "capped." If the camera detects a cap and the retention bar is not present on the sample rack, the system will generate the message 'Error - 6013: Has cap, no…
FDA · DeviceAbbott Molecular, Inc.Worldwide distribution - US Nationwide and the countries ARGENTINA, AUSTRALIA,…Official notice → - 2024-03-06
- US
Abbott Molecular, Inc. recalls Wash station: M1000 Wash Station Assembly & DITI Slide, REF 04J72-28* (*This part number is a spare to the M2000sp.)
Products that were intended for export only which were not approved or registered in accordance with U.S. specifications were shipped to U.S. customers.
FDA · DeviceAbbott Molecular, Inc.US Nationwide distribution in the states of AL, CA, IL, MA, MD, MN, NY, and PA.Official notice → - 2023-12-06
- US
Abbott Molecular, Inc. recalls Alinity m HCV AMP kit, List (REF) Numbers: a) 08N50-095 and b) 08N50-090. The Alinity m HCV assay is an in vitro reverse…
Abbott has received reports of an increase in reactive negative controls and false positive results in patient samples when using the Identified Lots of Alinity m HCV AMP Kit.
- 2023-04-12
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Abbott Molecular, Inc. recalls Abbott Alinity m System, REF 08N53-002, containing Amplification Detetction Unit (ADU) #4.
The instrument was found to be installed without plunger assemblies in the clamp bar for an Amplification Detection Unit. After correction of the issue, the instrument was returned for use without calibration. This…
FDA · DeviceAbbott Molecular, Inc.US Distribution to state of: PA, a government account.Official notice →
Other drugs & medical recalls in the United States
- 2025-04-30
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Straumann USA LLC recalls WB XL Anatomic Healing Abutment XC. Endosseous Dental Implant Abutments.
Incorrect blister labelling.
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Micro-X Ltd. recalls Brand Name: Rover Product Name: Mobile X-ray System Model/Catalog Number:MXU-RV35 Product Description: Rover Mobile X-rays System…
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software issue that causes an error screen on a portable vital signs monitor when attaching video Laryngoscope.
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When DxI 9000 Access Immunoassay Analyzer is connected to a host system (laboratory information system (LIS) or middleware) and has accumulated canceled QC test results that were not sent by LIS, the analyzer may lose…
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