Thermo SCIENTIFIC Sensititre Cation Adjusted AutoRead… recallZ-1947-2025 · Remel, Inc · initiated May 1, 2025
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Remel, Inc or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Product may have an off color affecting perfomance
FDA root cause category: Under Investigation by firm
What the company is doing
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 [email protected] 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 [email protected]."
Recall details
- Recall number
- Z-1947-2025
- Status
- Open, Classified
- Initiated by the company
- May 1, 2025
- Posted by the FDA
- Jun 11, 2025
- Recalling firm
- Remel, Inc
- Quantity
- 70 units
- Product code
- JWY
- FDA submissions
- K111429
- Distribution
- Worldwide - US Nationwide distribution in the states of AL, GA, KY, VA and the countries of Canada, UK.
Product description
Thermo SCIENTIFIC Sensititre Cation Adjusted AutoRead Mueller-Hinton Broth w/ TES w/ Lysed Horse Blood, REF CP11410; invitro diagnostic device
Code information (models, lots, serial numbers)
UDI/DI 848838018855, lot 226414
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- NA CP114-10Remel, Inc. · Culture Media, Antimicrobial Susceptibility Test, Mueller Hinton Agar/Broth1 recall0 reports
Other devices under the same FDA submission
1 device cleared under K111429 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- NA CP112-10Remel, Inc. · Manual Antimicrobial Susceptibility Test Systems1 recall0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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