FDA recall Z-1947-2025

Remel, Inc · Class II · device

Product

Thermo SCIENTIFIC Sensititre Cation Adjusted AutoRead Mueller-Hinton Broth w/ TES w/ Lysed Horse Blood, REF CP11410; invitro diagnostic device

Reason for recall

Product may have an off color affecting perfomance

Distribution

Worldwide - US Nationwide distribution in the states of AL, GA, KY, VA and the countries of Canada, UK.

Key facts

Status
Ongoing
Initiation date
2025-05-01
Report date
2025-06-18
Voluntary/Mandated
Voluntary: Firm initiated
Location
Lenexa, KS, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1947-2025