Drug recall
Alinity ci -series System Control¿Module, Part Number 03R70 01 Product Usage: The Alinity ci series System…
FDA recall event 83235 · Class II · Abbott Gmbh & Co. KG
Key facts
| Event ID | 83235 |
|---|---|
| Recall numbers | Z-2363-2019 |
| Recalling firm | Abbott Gmbh & Co. KG |
| Product type | Devices |
| Products | Alinity ci -series System Control¿Module, Part Number 03R70 01 Product Usage: The Alinity ci series System Control Module has a scalable design to provide full integration of clinical chemistry and… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Abbott has identified an issue with all on market versions (v2.6.0 and v2.6.1) of Alinity ci series Software where incorrect results may occur after a system Stop due to the Alinity i re use of… |
| Initiation date | Jun 10, 2019 |
| Report date | Sep 4, 2019 |
| Termination date | Jun 14, 2023 |
| City | Wiesbaden |
| Country | Germany |
| FEI number | 3002809144 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: