FDA Medical Device Recalls (openFDA)
Abbott Gmbh & Co. KG: Alinity i Processing Module, (a) Part Number 03R65-01 (b) Part Number A-30108552-01 (c) Part Number A-30109694-01 Product Usage: The Alinity i processing module is a fully automated immunoassay analyzer allowing random and continuous access, as well as priority and automated retest processing using chemiluminescent microparticle immunoassay (CMIA) technology. CMIA technology is used to determine the presence of antigens, antibodies, and analytes in samples.
- Recall number
- Z-0789-2019
- Recalling firm
- Abbott Gmbh & Co. KG
- Product
- Alinity i Processing Module, (a) Part Number 03R65-01 (b) Part Number A-30108552-01 (c) Part Number A-30109694-01 Product Usage: The Alinity i processing module is a fully automated immunoassay analyzer allowing random and continuous access, as well as priority and automated retest processing using chemiluminescent microparticle immunoassay (CMIA) technology. CMIA technology is used to determine the presence of antigens, antibodies, and analytes in samples.
- Status
- Terminated
- Initiated
- 2018-12-20
- Posted
- not on file
- Terminated
- 2022-09-19
- Reason
- Abbott has identified an issue with the Alinity i Gear Pump Assembly (part number A 30108552 01) resulting in foaming/bubbling out of the bottle reservoir for Concentrated Wash Buffer and an unexpected amount of dried residue of buffer. The foaming/bubbling is a result of an improper calibration of the pump s operating speed.
- Root cause
- Process control
- Action
- The firm initiated the recall by letter on 12/20/2018. The letter identified the affected product, problem and actions to be taken. The units will be serviced in the field. For questions contact Customer Service at 1-877-4ABBOTT. Customers outside the U.S., contact your local area Customer Service.
- Quantity
- 434 units
- Distribution
- Worldwide Distribution
- Lot, serial or model codes
- (a) Serial Numbers: Ai01001 - Ai01455, Ai01457, Ai01459 (b) all Serial Numbers (c) all Serial Numbers
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- JJE
- Firm FEI
- 3002809144
- Firm city
- Wiesbaden
- Firm state
- not on file
- Firm country
- Germany
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