FDA Enforcement
Class II
Ongoing
remel BLOOD AGAR EMB AGAR BIPLATE, REF R02041, QTY 100, for invitro diagnostic use
Recall: Z-1201-2025
·
Reported February 26, 2025
Enforcement
- Recall Number
- Z-1201-2025
- Event ID
- 96312
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Remel, Inc
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- February 26, 2025
- Initiation Date
- February 13, 2025
- Classification Date
- February 20, 2025
- Address
- 12076 Santa Fe Trail Dr, N/A, Lenexa, KS, 66215-3519, United States
Description
remel BLOOD AGAR EMB AGAR BIPLATE, REF R02041, QTY 100, for invitro diagnostic use
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.
Code Info
UDI/DI 848838003684, Lot Number 213971, exp. 2025-02-25
Distribution
US Nationwide distribution.
Quantity
316 units