Alinity i Processing Module — Class II medical device recall Z-0789-2019
Terminated recall by Abbott Gmbh & Co. KG, reported 2019-02-06. Abbott has identified an issue with the Alinity i Gear Pump Assembly (part number A 30108552 01) resulting in
| Recall number | Z-0789-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Abbott Gmbh & Co. KG, Wiesbaden, N/A, Germany |
| Recall initiated | 2018-12-20 |
| Classified | 2019-01-30 |
| Reported by FDA | 2019-02-06 |
| Terminated | 2022-09-19 |
| Quantity | 434 units |
| Serial numbers | AI01001, AI01455, AI01457, AI01459 |
| Model numbers | 03R65-01, A-30108552-01, A-30109694-01 |
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.
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0789-2019. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.