Skip to content
Recall Observatory FDA recall evidence

Device product

remel BLOOD AGAR EMB AGAR BIPLATE, REF R02041, QTY 100, for invitro diagnostic use

Z-1201-2025

February 13, 2025

Class II

Product summary

Firm
Remel, Inc
Event
Event 96312
Status
Ongoing
Classification
Class II
Quantity
316 units
Official record key
device-enforcement:Z-1201-2025

Official wording

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 information: UDI/DI 848838003684, Lot Number 213971, exp. 2025-02-25

Distribution pattern: US Nationwide distribution.

Derived failure modes

  • Microbial contamination

    reason.microbial_contamination · v1.0.0

    contamination of Listeria monocytogenes