Ortho-Clinical Diagnostics, INc. Recall 93238
Description: VITROS Chemistry Products Lipase Slides, Product Codes 1668409 (contains 60 Slides per Cartridge) and 8297749 (contains 18 slides per cartridge)
Ortho-Clinical Diagnostics, INc. Recall 93238 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0236-2024 |
| Event ID | 93238 |
| Event Description | VITROS Chemistry Products Lipase Slides, Product Codes 1668409 (contains 60 Slides per Cartridge) and 8297749 (contains 18 slides per cartridge) |
| Product Type | Devices |
| Distribution | US States: CA, CO, FL, GA, IL, IN, KS, NC, NY, TN, TX, VT. Canada, France, India, Japan, South Korea |
| Quantity | 342 units |
| Recall Reason | 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 result in a missed or delayed diagnosis of acute pancreatitis and may lead to diagnostic confusion in the setting of acute abdominal symptoms. Falsely elevated levels would not result in patient harm but may cause diagnostic confusion and a delay in accurate diagnosis of a patient with abdominal pain. |
| Device Classification | 20231115 |
| Device Code Info | Product Code 1668409: UDI-DI: 10758750009510, Affected Lots: 5905-3348-1557; Product Code 8297749: UDI-DI: 10758750004683, Affected Lots: 5905-3348-2899 |
| Center Classification Date | 20231106 |
| Recall Initiation Date | 20230912 |
| Recalling Firm | Ortho-Clinical Diagnostics, INc. |
| Initial Notification | Letter |
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