Remel, Inc: Device Recall
Recall #Z-1200-2025 · 02/13/2025
Class II: Risk
Recall Details
- Recall Number
- Z-1200-2025
- Classification
- Class II
- Product Type
- Device
- Recalling Firm
- Remel, Inc
- Status
- Ongoing
- Date Initiated
- 02/13/2025
- Location
- Lenexa, KS, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 787 units
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.
Product Description
remel BLOOD AGAR MacCONKEY AGAR BIPLATE, REF R02049, QTY 100, for invitro diagnostic use
Distribution Pattern
US Nationwide distribution.
Other Recalls by Remel, Inc
- Class II: Risk 11/12/2025
- Class II: Risk 07/11/2025
- Class II: Risk 07/11/2025
- Class II: Risk 07/11/2025
- Class II: Risk 07/11/2025
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.