Device product
Thermo SCIENTIFIC Sensititre Cation Adjusted AutoRead Mueller-Hinton Broth w/ TES w/ Lysed Horse Blood, REF CP11410; invitro diagnostic device
Z-1947-2025
Product summary
- Firm
- Remel, Inc
- Event
- Event 96810
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 70 units
- Official record key
device-enforcement:Z-1947-2025
Official wording
Reason: Product may have an off color affecting perfomance
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.
Derived failure modes
-
Unknown
Product may have an off color affecting perfomance