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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices/Diagnostic Equipment

Alinity m System Diagnostic Instruments Recalled for Liquid Leak Hazard

Agency Publication Date: April 24, 2025
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Summary

Abbott Molecular, Inc. is recalling Alinity m System Diagnostic Instruments, including models 08N53-001, 08N53-002, and 08N53-032 (Refurbished). These instruments are automated systems used in laboratories for nucleic acid testing. The design of the system's solutions drawer may allow liquid waste or cleaning solutions to leak outside the machine and into the walking path of laboratory personnel. No injuries have been reported to date.

Risk

The leaked fluids can flow beyond the instrument's footprint, creating a significant slip-and-fall hazard for users in the laboratory. Depending on the nature of the leaked solutions, there may also be a risk of exposure to chemical or biological waste.

What You Should Do

  1. This recall involves Alinity m System Diagnostic Instruments (models 08N53-001, 08N53-002, and 08N53-032) used for automated nucleic acid testing.
  2. Identify if your instrument is affected by checking the model number and serial number on the device label. This recall affects all serial numbers for the listed models.
  3. Stop using the recalled product.
  4. Contact Abbott Molecular, Inc. or your authorized distributor to arrange for a return, replacement, or professional correction of the instrument's drawer enclosure.
  5. Call the FDA at 1-888-463-6332 (1-888-INFO-FDA) for additional information regarding medical device recalls.

Your Remedy Options

๐Ÿ“‹Other Action

Manufacturer-initiated correction or replacement.

How to: Stop using the recalled product. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: Alinity m System Diagnostic Instrument
Variants: Refurbished
Model / REF:
08N53-001
08N53-002
08N53-032
Serial Numbers:
All Serial Numbers
UDI:
00884999047389
00884999048034
00884999047587

Recall #: Z-1665-2025

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 96559
Status: Active
Manufacturer: Abbott Molecular, Inc.
Sold By: Abbott Molecular, Inc.
Manufactured In: United States
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.