FDA Medical Device Recalls (openFDA)
Abbott Molecular, Inc.: Abbott Alinity m System, REF 08N53-002, containing Amplification Detetction Unit (ADU) #4.
- Recall number
- Z-1349-2023
- Recalling firm
- Abbott Molecular, Inc.
- Product
- Abbott Alinity m System, REF 08N53-002, containing Amplification Detetction Unit (ADU) #4.
- Status
- Open, Classified
- Initiated
- 2022-11-11
- Posted
- 2023-04-06
- Terminated
- not on file
- Reason
- 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.
- Root cause
- Under Investigation by firm
- Action
- 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.
- Quantity
- 1
- Distribution
- US Distribution to state of: PA, a government account.
- Lot, serial or model codes
- Alinity m System Serial #01015, UDI: (01)00884999048034(11)220505(21)01015(240)08N53-002; ADU Serial #AMP05139.
- 510(k) numbers
- not on file
- PMA numbers
- ["P190025"]
- Product code
- OOI
- 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