Abbott Molecular, Inc. Alinity m System, Part No. 08N53-002 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
Alinity m System, Part No. 08N53-002
Brand
Abbott Molecular, Inc.
Lot Codes / Batch Numbers
Model 08N53-002, all serial numbers
Products Sold
Model 08N53-002, all serial numbers
Abbott Molecular, Inc. is recalling Alinity m System, Part No. 08N53-002 due to There is a potential for abnormal (non-sigmoidal) amplification curves.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
There is a potential for abnormal (non-sigmoidal) amplification curves.
Recommended Action
Per FDA guidance
On December 06, 2021 Abbott Molecular issued a Product Correction letter to all customers who received an Alinity m instrument (List Number 08N53 002). Customers are instructed to follow the Necessary Actions outlined in the Customer Letter until an Abbott Molecular representative adjusts the customers clamp bar. Abbott personnel will follow up with customers by e mailing and or follow up visits/phone calls.
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 noticePage updated: Jan 10, 2026