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U.S. Department of Health and Human Services

Class 2 Device Recall Thermo SCIENTIFIC Sensititre

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 Class 2 Device Recall Thermo SCIENTIFIC Sensititresee related information
Date Initiated by FirmMay 01, 2025
Date PostedJune 11, 2025
Recall Status1 Open3, Classified
Recall NumberZ-1947-2025
Recall Event ID 96810
510(K)NumberK111429 
Product Classification Manual antimicrobial susceptibility test systems - Product Code JWY
ProductThermo SCIENTIFIC Sensititre Cation Adjusted AutoRead Mueller-Hinton Broth w/ TES w/ Lysed Horse Blood, REF CP11410; invitro diagnostic device
Code Information UDI/DI 848838018855, lot 226414
Recalling Firm/
Manufacturer		 Remel, Inc
12076 Santa Fe Trail Dr
Lenexa KS 66215-3519
For Additional Information ContactErica Knox
800-255-6730
Manufacturer Reason
for Recall		Product may have an off color affecting perfomance
FDA Determined
Cause 2		Under Investigation by firm
ActionThermo 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."
Quantity in Commerce70 units
DistributionWorldwide - US Nationwide distribution in the states of AL, GA, KY, VA and the countries of Canada, UK.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = JWY
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