Chrysalis Intelligence · Sponsors · Remel Europe Ltd.

Remel Europe Ltd.

0 510(k) clearances · 3 recalls

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Total clearances
0
None → None
Last 12 months
0
Product codes
0
Most recent
—
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Clearance cadence by quarter

Portfolio

Product codes worked

Code Device name Class Specialty Clearances Most recent
Safety

Recalls (3)

Class I (serious)
0
Risk of injury / death
Total recalls
3
Currently ongoing
2
Most recent
2026-07-17
DateSeverityStatusRecall # ProductCodeReason
2026-07-17 Class II Ongoing Z-2927-2026 Thermo Fisher Diagnostics Neisseria meningitidis Gp C 2ml/VL, Product Number R30166901; invitro diagnostics — Certain lots of Neisseria meningitidis Gp C 2ml/VL, R30166901, are not performing to IFU criteria not positive to ATCC13102 within 60 Seconds.
2026-03-25 Class II Ongoing Z-1923-2026 Oxoid Agglutinating Sera, Salmonella 9-0 R30957301 — Affected lots are not performing to IFU criteria showing cross reactions with 2-0 within 60 seconds. Cross-reactivity may result in the misidentification of a S…
2020-07-23 Class II Terminated Z-2920-2020 Thermo Scientific Remel Bordetella pertussis Agglutinating Serum Product Number: R30165501, UDI-DI: 05056080501826 - Pro… — Thermo Scientific" Remel" Bordetella pertussis Agglutinating Serum (R30165501/ZM10) is not performing, resulting in the potential for false negative results for…
Filings

510(k) clearances (none indexed)

Date K-number Device Code Class Specialty
Data source: openFDA · Generated 2026-08-26 09:36 · Last ingest 2026-08-26T13:35:45.365163 · Pipeline: Chrysalis Intelligence