Z-1947-2025 Class II Ongoing
FDA device recall Z-1947-2025 was initiated by Remel, Inc on May 1, 2025 and is designated Class II. Reason for recall: Product may have an off color affecting perfomance The recall status is ongoing. Affected quantity: 70 units.
Recall Details
- Product Type
- Devices
- Report Date
- June 18, 2025
- Initiation Date
- May 1, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 70 units
Product Description
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 Pattern
Worldwide - US Nationwide distribution in the states of AL, GA, KY, VA and the countries of Canada, UK.
Code Information
UDI/DI 848838018855, lot 226414