Z-0789-2019 Class II Terminated
FDA device recall Z-0789-2019 was initiated by Abbott Gmbh & Co. KG on December 20, 2018 and is designated Class II. Reason for recall: 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 unexpecte… The recall status is terminated (terminated September 19, 2022). Affected quantity: 434 units.
Recall Details
- Product Type
- Devices
- Report Date
- February 6, 2019
- Initiation Date
- December 20, 2018
- Termination Date
- September 19, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 434 units
Product Description
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.
Reason for Recall
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.
Distribution Pattern
Worldwide Distribution
Code Information
(a) Serial Numbers: Ai01001 - Ai01455, Ai01457, Ai01459 (b) all Serial Numbers (c) all Serial Numbers