FDA Medical Device Recalls (openFDA)
Abbott Molecular, Inc.: The Alinity m System, REF 08N53-002, For In Vitro Diagnostic Use.
- Recall number
- Z-1518-2022
- Recalling firm
- Abbott Molecular, Inc.
- Product
- The Alinity m System, REF 08N53-002, For In Vitro Diagnostic Use.
- Status
- Completed
- Initiated
- 2022-07-19
- Posted
- not on file
- Terminated
- not on file
- Reason
- Incorrect optical calibration
- Root cause
- Nonconforming Material/Component
- Action
- 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.
- Quantity
- 1
- Distribution
- There was only foreign distribution to Italy.
- Lot, serial or model codes
- Serial Number 00654
- 510(k) numbers
- not on file
- PMA numbers
- ["P190025"]
- Product code
- MZP
- Firm FEI
- 3005248192
- Firm city
- Des Plaines
- Firm state
- IL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28