Device 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.
Z-0789-2019
Product summary
- Event
- Event 81916
- Status
- Terminated
- Classification
- Class II
- Quantity
- 434 units
- Official record key
device-enforcement:Z-0789-2019
Official wording
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.
Code information: (a) Serial Numbers: Ai01001 - Ai01455, Ai01457, Ai01459 (b) all Serial Numbers (c) all Serial Numbers
Distribution pattern: Worldwide Distribution
Derived failure modes
-
Unknown
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.