Abbott Molecular, Inc. Abbott Alinity m System, REF 08N53-002, containing Amplification Detetction Unit (ADU) #4. Recall
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Abbott Alinity m System, REF 08N53-002, containing Amplification Detetction Unit (ADU) #4.
Brand
Abbott Molecular, Inc.
Lot Codes / Batch Numbers
Alinity m System Serial #01015, UDI: (01)00884999048034(11)220505(21)01015(240)08N53-002, ADU Serial #AMP05139.
Products Sold
Alinity m System Serial #01015, UDI: (01)00884999048034(11)220505(21)01015(240)08N53-002; ADU Serial #AMP05139.
Abbott Molecular, Inc. is recalling Abbott Alinity m System, REF 08N53-002, containing Amplification Detetction Unit (ADU) #4. due to The instrument was found to be installed without plunger assemblies in the clamp bar for an Amplification Detection Unit. After correction of the iss. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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 would result in a potential for delay of results and incorrect results.
Recommended Action
Per FDA guidance
The field service engineer installed the missing plunger assembly in the clamp bar while at the consignee location on 11/11/2022. The recalling firm issued the recall letter on 3/1/2023 via overnight mail to their sole consignee. The letter explains the issue, the potential impact, and the necessary actions, which includes placing the impacted ADU out of service and contacting Abbott technical support regarding concerns about the performance of the instrument or results. The letter is to be reviewed with the Medical Director or Laboratory Management and the consignee is to follow their laboratory protocol regarding the need for review of previously reported patient results using the affected system. A customer reply form is enclosed with the letter to acknowledge receipt and to indicate it was disseminated to all users, understood, and implemented. If you have any questions regarding this communication, please contact your local Abbott representative or call DVP Quality Assurance, at 224-361-7000.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
PA
Page updated: Jan 10, 2026