FDA Medical Device Recalls (openFDA)
Remel Europe Ltd.: Thermo Fisher Diagnostics Neisseria meningitidis Gp C 2ml/VL, Product Number R30166901; invitro diagnostics
- Recall number
- Z-2927-2026
- Recalling firm
- Remel Europe Ltd.
- Product
- Thermo Fisher Diagnostics Neisseria meningitidis Gp C 2ml/VL, Product Number R30166901; invitro diagnostics
- Status
- Open, Classified
- Initiated
- 2026-07-17
- Posted
- 2026-08-07
- Terminated
- not on file
- Reason
- Certain lots of Neisseria meningitidis Gp C 2ml/VL, R30166901, are not performing to IFU criteria not positive to ATCC13102 within 60 Seconds.
- Root cause
- Under Investigation by firm
- Action
- Thermo 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
- 26 units
- Distribution
- US Nationwide distribution.
- Lot, serial or model codes
- 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.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- GTJ
- Firm FEI
- 3003750284
- Firm city
- West Ken Dartford
- Firm state
- not on file
- Firm country
- United Kingdom
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28