Drug recall
VITROS Chemistry Products Lipase Slides, Product Codes 1668409 (contains 60 Slides per Cartridge) and 8297749…
FDA recall event 93238 · Class II · Ortho-Clinical Diagnostics, INc.
Key facts
| Event ID | 93238 |
|---|---|
| Recall numbers | Z-0236-2024 |
| Recalling firm | Ortho-Clinical Diagnostics, INc. |
| Product type | Devices |
| Products | VITROS Chemistry Products Lipase Slides, Product Codes 1668409 (contains 60 Slides per Cartridge) and 8297749 (contains 18 slides per cartridge) |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Products 1668409 and 8297749 may contain VITROS Lipase Slides with an abnormality which could cause -46% to +86% bias in lipase results depending on how the slides are used. Falsely low levels could… |
| Initiation date | Sep 12, 2023 |
| Report date | Nov 15, 2023 |
| City | Rochester |
| State | NY |
| Country | United States |
| FEI number | 1000305840 |
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: