FDA Medical devices recall ·
Thermo SCIENTIFIC Sensititre Cation Adjusted AutoRead Mueller-Hinton Broth… recall
- Recall number
- Z-1947-2025
- Date
- (initiated May 1, 2025)
- Company / brand
- Remel, Inc
12076 Santa Fe Trail Dr, Lenexa, KS, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 70 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Thermo SCIENTIFIC Sensititre Cation Adjusted AutoRead Mueller-Hinton Broth w/ TES w/ Lysed Horse Blood, REF CP11410; invitro diagnostic device
Why was it recalled?
Product may have an off color affecting perfomance
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
UDI/DI 848838018855, lot 226414
Distribution
Worldwide - US Nationwide distribution in the states of AL, GA, KY, VA and the countries of Canada, UK.
States: Alabama Georgia Kentucky Virginia
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-1947-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.