ACTIM OY Recall 93845
Description: Actim PROM dipstik, REF 30831ETUS; qualitative immunoassay rapid test for rupture of fetal membrane
ACTIM OY Recall 93845 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1592-2024 |
| Event ID | 93845 |
| Event Description | Actim PROM dipstik, REF 30831ETUS; qualitative immunoassay rapid test for rupture of fetal membrane |
| Product Type | Devices |
| Distribution | US Nationwide distribution in the state of Connecticut. |
| Quantity | 6471 kits |
| Recall Reason | Interference testing has shown that the presence of personal lubricants in the vaginal specimen can interfere with the PROM test result by providing a false positive result. |
| Device Classification | 20240424 |
| Device Code Info | UDI/DI 06430030990608, All serial numbers in distribution |
| Center Classification Date | 20240417 |
| Recall Initiation Date | 20231123 |
| Recalling Firm | ACTIM OY |
| Initial Notification | |
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