Z-1201-2025 Class II Ongoing
FDA device recall Z-1201-2025 was initiated by Remel, Inc on February 13, 2025 and is designated Class II. Reason for recall: 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. The recall status is ongoing. Affected quantity: 316 units.
Recall Details
- Product Type
- Devices
- Report Date
- February 26, 2025
- Initiation Date
- February 13, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 316 units
Product Description
remel BLOOD AGAR EMB AGAR BIPLATE, REF R02041, QTY 100, for invitro diagnostic use
Reason for Recall
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.
Distribution Pattern
US Nationwide distribution.
Code Information
UDI/DI 848838003684, Lot Number 213971, exp. 2025-02-25