DeviceSignal · Recall classified
Remel Europe Ltd.
FDA classified a device recall on 2026-08-07 · Class II · Z-2927-2026
EventRecall classified
Effective2026-08-07
ClassificationClass II
On 2026-08-07 the FDA classified a device recall from Remel Europe Ltd. as Class II. Product: Thermo Fisher Diagnostics Neisseria meningitidis Gp C 2ml/VL, Product Number R30166901…. Recall Z-2927-2026. The firm initiated it on 2026-07-17. This reports the classification FDA published on that date.
Reported facts
- Recall number
- Z-2927-2026
- Classification
- Class II
- Classified on
- 2026-08-07
- Initiated on
- 2026-07-17
- Firm
- Remel Europe Ltd.
- Reason
- Certain lots of Neisseria meningitidis Gp C 2ml/VL, R30166901, are not performing to IFU criteria not positive to ATCC13102 within 60 Seconds.
- Product
- Thermo Fisher Diagnostics Neisseria meningitidis Gp C 2ml/VL, Product Number R30166901; invitro diagnostics
Every field above is as fda_device_enforcement published it. Nothing on this page is our interpretation.
Provenance
- Source
- fda_device_enforcement
- Source record
Z-2927-2026- Snapshot hash
ab5ada73bf212eb52a548aab0968a0fcee42807c61b0350e60e24bb6e2beed72- Source URL
- https://download.open.fda.gov/device/enforcement/device-enforcement-0001-of-0001.json.zip
- Observed
- 2026-09-08T16:22:09.483Z
- Transform
fda_device_enforcement_to_recall v1- Event rule
fda_device_recall_classified v1- Event key
877e0b4e7f1288d7dc4d978108ca5d91cd59e0103fcc0ed98619258c6497d2ea- Signal type
device_recall.classified
Source terms that apply
- This is not a public alerting service and must not be used to notify patients or the public
- We do not report whether a recall is still open; FDA does not maintain that after classification
- Nothing here is a medical or clinical decision aid
- Not affiliated with, endorsed by, or certified by the FDA
Data provided by the U.S. Food and Drug Administration (https://open.fda.gov)