Fujirebio Diagnostics, Inc.
1 recall(s) on record — most severe on record: Class II.
Recalls by year
- Recalls (1)
Registered facilities (7)
- Fujirebio Inc. Ube Facility FEI 3014643041 · JP
- Fujirebio Diagnostics, Inc. FEI 2521625 · PA
- Fujirebio Inc. FEI 3002895169 · JP
- Fujirebio Diagnostics, Inc. FEI 1643621 · TX
- Fujirebio Europe N.V. FEI 3002608770 · BE
- Fujirebio Diagnostics AB FEI 3027273565 · SE
- Fujirebio Diagnostics, AB FEI 3000125561 · SE
Recalls & enforcement
- Class IIOngoing2025-12-11Customers may experience inaccurate test results by observing a higher frequency of classification in the indeterminate and positive zone and/or low specificity when compared back to FDA-cleared CSF ratio/PET imaging, due to falsely elevated positive ratio or falsely elevated ind…
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. We restate the public record only — measured facts, never risk verdicts.
Cite this record
RegWarden. “Fujirebio Diagnostics, Inc. — FDA compliance profile.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/company/oo-10022860-fujirebio-diagnostics-inc/
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