🔍 RecallPedia

Alinity m System, Part Number: 08N53-002

Class I - Dangerous
🏥 Medical Devices Recalled: March 20, 2024 Abbott Molecular Other Medical Devices Nationwide

What Should You Do?

  1. Check if you have this product:
    Part Number: 08N53-002; UD/DI: 00884999048034. Not Serial Number specific
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Abbott Molecular, Inc.
Reason for Recall:
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 retention bar." Abbott has identified an issue concerning the use of certain third-party Universal Transport Medium (UTM) tubes on the Alinity m System. This issue has been observed with Copan UTM-RT 3 mL Without Beads Transport & Preservation Medium for Viral Molecular Diagnostics Testing, Part Number (PN) 3C047N. However, it is possible that other third party manufactured tubes could experience the same issue.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
ongoing

Product Information

Full Description:

Alinity m System, Part Number: 08N53-002

Product Codes/Lot Numbers:

Part Number: 08N53-002; UD/DI: 00884999048034. Not Serial Number specific

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1602-2024

Related Recalls

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.

Abbott Molecular

Class I - Dangerous

There were reports of an increase in reactive negative controls and false positive results.

Apr 28, 2025 Implants & Prosthetics Nationwide View Details →

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

Abbott Molecular

Class I - Dangerous

There were reports of an increase in reactive negative controls and false positive results.

Apr 28, 2025 Diagnostic Equipment Nationwide View Details →

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).

Abbott Molecular

Class I - Dangerous

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 walking-path of the user.

Mar 20, 2025 Diagnostic Equipment Nationwide View Details →