Recall Z-0789-2019
Abbott Gmbh & Co. KG · initiated December 20, 2018
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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.
Codes / lots: (a) Serial Numbers: Ai01001 - Ai01455, Ai01457, Ai01459 (b) all Serial Numbers (c) all Serial Numbers
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.
FDA-determined cause: Process control
Action taken
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.
Details
- Recall number
- Z-0789-2019
- Initiated
- December 20, 2018
- Terminated
- September 19, 2022
- Product code
- JJE – Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
- Quantity
- 434 units
- Distribution
- Worldwide Distribution
- Recalling firm
- Abbott Gmbh & Co. KG, Wiesbaden