Drug recall
Alinity c Processing Module REF 03R67-01 The Alinity c Processing Module is a fully automated chemistry…
FDA recall event 93355 · Class II · Abbott Laboratories
Key facts
| Event ID | 93355 |
|---|---|
| Recall numbers | Z-0680-2024, Z-0681-2024, Z-0682-2024 |
| Recalling firm | Abbott Laboratories |
| Product type | Devices |
| Products | Alinity c Processing Module REF 03R67-01 The Alinity c Processing Module is a fully automated chemistry analyzer allowing random and continuous access, as well as priority and automated retest…, Alinity i Processing Module REF 03R65-01 The Alinity i Processing Module is a fully automated immunoassay analyzer allowing random and continuous access, as well as priority and automated retest…, ARCHITECT c4000 Processing Module REF: 02P24-01 02P24-02 02P24-40 01R24-56 01R25-56 The Abbott ARCHITECT c4000 Processing Module is designed to perform automated chemistry tests, utilizing photometry… |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | The devices contain a dry natural rubber (latex) subcomponent, which are not labeled as containing dry natural rubber(latex). |
| Initiation date | Oct 19, 2023 |
| Report date | Jan 17, 2024 |
| City | Irving |
| State | TX |
| Country | United States |
| FEI number | 3016438761 |
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: