FDA Enforcement
Class II
Ongoing
Strep Selective II Agar, Product Number R01859
Recall: Z-2224-2025
·
Reported August 6, 2025
Enforcement
- Recall Number
- Z-2224-2025
- Event ID
- 97224
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Remel, Inc
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- August 6, 2025
- Initiation Date
- July 11, 2025
- Classification Date
- July 31, 2025
- Address
- 12076 Santa Fe Trail Dr, Lenexa, KS, 66215-3519, United States
Description
Strep Selective II Agar, Product Number R01859
Reason
The products may contain surface and subsurface contamination of Listeria monocytogenes.
Code Info
UDI-DI: 848838003158; Lot Numbers: 271613
Distribution
US Nationwide distribution.
Quantity
371 units