Recall Z-0789-2019 ยท JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
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 determin
| Date | Dec 20, 2018 |
| Status | Terminated |
| 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.