—#213705

Product

Thermo SCIENTIFIC Sensititre Cation Adjusted AutoRead Mueller-Hinton Broth w/ TES w/ Lysed Horse Blood, REF CP11410; invitro diagnostic device

FDA product code: JWY — Manual Antimicrobial Susceptibility Test Systems
Device class: Class 2
Medical specialty: Microbiology
510(k) numbers: K111429
Affected lot / code info: UDI/DI 848838018855, lot 226414

Why it was recalled

Product may have an off color affecting perfomance

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

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."

Recalling firm

Firm: Remel, Inc
Address: 12076 Santa Fe Trail Dr, Lenexa, Kansas 66215-3519

Distribution

Distribution pattern: Worldwide - US Nationwide distribution in the states of AL, GA, KY, VA and the countries of Canada, UK.

Timeline

Recall initiated: 2025-05-01
Posted by FDA: 2025-06-11
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #213705. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.