Thermo SCIENTIFIC Sensititre Cation Adjusted AutoRead Mueller-Hinton Broth w/ TES w/ Lysed Horse Blood, REF CP11410; invitro diagnostic device
- Company
- Remel Inc
- Recall Initiated
- May 1, 2025
- Posted
- June 11, 2025
- Recall Number
- Z-1947-2025
- Quantity
- 70 units
- Firm Location
- Lenexa, KS
Reason for Recall
Product may have an off color affecting perfomance
Distribution
Worldwide - US Nationwide distribution in the states of AL, GA, KY, VA and the countries of Canada, UK.
Lot / Code Info
UDI/DI 848838018855, lot 226414
Root Cause
Under Investigation by firm
Action Taken
Thermo Fisher Scientific issued an Urgent: Medical Device Recall notice to its consignees on 05/01/2025 via USPS First Class Mail. The notice explained the issue with the device, potential risk to health, and requested the following: "Accordingly, in keeping with our Quality Policy, we request that a review of test results should be evaluated by an appropriate technical expert. Please keep this notification on file. Also, destroy any remaining inventory of the lot listed above and complete the accompanying Acknowledgement form. Return the completed form indicating number of units destroyed via email to MBD.vigilance@thermofisher.com for your replacement/credit to be processed. This notice needs to be passed on to all who need to be aware within your organization or to any organization where the potentially affected products have been transferred. If you have any questions, please contact our Technical Services Department at 800-255-6730 (US) or email microbiology.ts.us@thermofisher.com."