Sensititre AutoRead Broth (Remel) – Color Performance Issue (2025)
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Thermo SCIENTIFIC Sensititre Cation Adjusted AutoRead Mueller-Hinton Broth w/ TES w/ Lysed Horse Blood, REF CP11410; invitro diagnostic device
Brand
Remel, Inc
Lot Codes / Batch Numbers
UDI/DI 848838018855, lot 226414
Products Sold
UDI/DI 848838018855, lot 226414
Remel, Inc is recalling Thermo SCIENTIFIC Sensititre Cation Adjusted AutoRead Mueller-Hinton Broth w/ TES w/ Lysed Horse Blo due to Product may have an off color affecting perfomance. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Product may have an off color affecting perfomance
Recommended Action
Per FDA guidance
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."
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026