Remel, Inc Recall 96312
Description: remel BLOOD AGAR EMB AGAR BIPLATE, REF R02041, QTY 100, for invitro diagnostic use
Remel, Inc Recall 96312 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1201-2025 |
| Event ID | 96312 |
| Event Description | remel BLOOD AGAR EMB AGAR BIPLATE, REF R02041, QTY 100, for invitro diagnostic use |
| Product Type | Devices |
| Distribution | US Nationwide distribution. |
| Quantity | 316 units |
| Recall Reason | Product may contain surface and subsurface contamination of Listeria monocytogenes which is typically visible immediately upon removal from the packaging, appearing on the blood side of the biplate. |
| Device Classification | 20250226 |
| Device Code Info | UDI/DI 848838003684, Lot Number 213971, exp. 2025-02-25 |
| Center Classification Date | 20250220 |
| Recall Initiation Date | 20250213 |
| Recalling Firm | Remel, Inc |
| Initial Notification | Letter |
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