Remel, Inc: Medical Device Recall in 2025 - (Recall #: Z-1947-2025)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2025.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: May 1, 2025

Date Posted: June 18, 2025

Recall Number: Z-1947-2025

Event ID: 96810

Reason for Recall:

Product may have an off color affecting perfomance

Status: Ongoing

Product Quantity: 70 units

Code Information:

UDI/DI 848838018855, lot 226414

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated