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U.S. Department of Health and Human Services

Class 2 Device Recall Thermo Fisher Diagnostics

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 Class 2 Device Recall Thermo Fisher Diagnosticssee related information
Date Initiated by FirmJuly 17, 2026
Date PostedAugust 07, 2026
Recall Status1 Open3, Classified
Recall NumberZ-2927-2026
Recall Event ID 99450
Product Classification Antisera, all groups, n. Meningitidis - Product Code GTJ
ProductThermo Fisher Diagnostics Neisseria meningitidis Gp C 2ml/VL, Product Number R30166901; invitro diagnostics
Code Information UDI/DI 05056080501161, Lot Numbers: 6214791, exp. 18/03/2025; 6175327, exp. 04/12/2027; 6148809, exp. 30/09/2027; 6002010, exp. 31/07/2027.
FEI Number 3003750284
Recalling Firm/
Manufacturer		 Remel Europe Ltd.
Clipper Boulevard West
Ken
Dartford United Kingdom
For Additional Information ContactErica Knox
800-255-6730
Manufacturer Reason
for Recall		Certain lots of Neisseria meningitidis Gp C 2ml/VL, R30166901, are not performing to IFU criteria not positive to ATCC13102 within 60 Seconds.
FDA Determined
Cause 2		Under Investigation by firm
ActionThermo Fisher Scientific issued an Urgent: Medical Device Recall notice to its consignees on 7/17/2026 via USPS, first class mail. The notice explained the issue, risk to health, and requested the following: "ACTIONS TO BE TAKEN BY THE CUSTOMER: Our records indicate that you have received above products. Accordingly, in keeping with our Quality Policy, we request that you please notify any personnel who need to be aware of this issue. Laboratory professionals are advised to destroy any remaining inventory of lots listed above. Please complete the accompanying Acknowledgement form and return the completed form indicating number of units destroyed via email to MBD.vigilance@thermofisher.com in order for your replacement/credit to be processed. Complete and return the response form even if you no longer have the affected product on hand. Please keep this notification on file. 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 Commerce26 units
DistributionUS Nationwide distribution.
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.
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