FDA recall Z-1200-2025

Remel, Inc · Class II · device

Product

remel BLOOD AGAR MacCONKEY AGAR BIPLATE, REF R02049, QTY 100, for invitro diagnostic use

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.

Distribution

US Nationwide distribution.

Key facts

Status
Ongoing
Initiation date
2025-02-13
Report date
2025-02-26
Voluntary/Mandated
Voluntary: Firm initiated
Location
Lenexa, KS, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1200-2025