FDA Enforcement
Class II
Ongoing
Thermo SCIENTIFIC Sensititre Cation Adjusted AutoRead Mueller-Hinton Broth w/ TES w/ Lysed Horse Blood, REF CP11410; invitro diagnostic device
Recall: Z-1947-2025
·
Reported June 18, 2025
Enforcement
- Recall Number
- Z-1947-2025
- Event ID
- 96810
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Remel, Inc
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- June 18, 2025
- Initiation Date
- May 1, 2025
- Classification Date
- June 11, 2025
- Address
- 12076 Santa Fe Trail Dr, Lenexa, KS, 66215-3519, United States
Description
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
Code Info
UDI/DI 848838018855, lot 226414
Distribution
Worldwide - US Nationwide distribution in the states of AL, GA, KY, VA and the countries of Canada, UK.
Quantity
70 units