Alinity m System (Abbott Molecular) – Optical Calibration Error (2022)
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
The Alinity m System, REF 08N53-002, For In Vitro Diagnostic Use.
Brand
Abbott Molecular, Inc.
Lot Codes / Batch Numbers
Serial Number 00654
Products Sold
Serial Number 00654
Abbott Molecular, Inc. is recalling The Alinity m System, REF 08N53-002, For In Vitro Diagnostic Use. due to Incorrect optical calibration. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Incorrect optical calibration
Recommended Action
Per FDA guidance
The recalling firm issued a letter dated 7/19/2022 via Abbott representative delivery on 7/19/2022 confirming the issue the customer had with their instrument. The letter also said the impacted ADU4 module was taken out of service on 1/25/2022 and was then replaced with a new module on 3/22/2022. The letter discussed the potential impact and the necessary actions to take which included completing and returning the Customer Reply Form and reviewing this information with laboratory personnel and retain the communication for future reference.
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