RecallRadar

FDA Device recall Z-1947-2025

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

On 2025-06-18 the FDA classified a Class II recall of Thermo SCIENTIFIC Sensititre Cation Adjusted AutoRead Mueller-Hinton Broth w/ TES w/ Lysed Horse Blood, REF CP11410 by Remel, citing product may have an off color affecting perfomance.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-1947-2025
ClassificationClass II
Statusongoing
Initiated2025-05-01
Published2025-06-18
Last updated2026-09-13 11:57 UTC
CompanyRemel
DistributionUS

Product

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

Reason

Product may have an off color affecting perfomance

Identifiers

code_infoUDI/DI 848838018855, lot 226414

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1947-2025%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.