FDA Enforcement Class II Ongoing

Blood Agar,5% Sheep Blood 100/PK, Product Number R01202

Recall: Z-2223-2025 · Reported August 6, 2025

Enforcement

Recall Number
Z-2223-2025
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

Blood Agar,5% Sheep Blood 100/PK, Product Number R01202

Reason

The products may contain surface and subsurface contamination of Listeria monocytogenes.

Code Info

UDI-DI: 848838000645; Lot Numbers: 271595, 271596

Distribution

US Nationwide distribution.

Quantity

1552 units