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BIOPHEN Protein C 2.5
Model 221202 · HYPHEN BIOMED · DI 03663537008221
GGP — Test, Qualitative And Quantitative Factor Deficiency · Class II · 21 CFR 864.7290
UDILibrary device dossier · generated 2026-09-15 · sources: FDA GUDID, openFDA (recalls, MAUDE, 510(k)/PMA), FDA Data Dashboard (inspections, compliance actions), 510(k) summary documents.
Recall history (1)
| Initiated | Recall # | Class | Status | Reason | Link basis |
|---|---|---|---|---|---|
| 2023-02-01 | Z-1227-2023 | Class II | Open, Classified | New warnings and precautionary statements on product labelling: Reagent 2 (R2) of BIOPHEN Protein C 5 contains the chemical substance - Cesium Chloride which changed classification and has become hazardous according to the CLP regulation ((EC) No 1272/2008) is suspected of damaging fertility | k number procode |
Adverse-event reports — MAUDE (0)
Caveat (required reading): MAUDE report counts cannot be used to compute incidence rates or compare device safety. Reporting is incomplete, duplicated, and spikes with publicity; there is no denominator of devices in use. The peer line is a reporting baseline (average device in the same product code), not a risk measure.
| Month | This device (reports) | Product-code average (reports per device) |
|---|---|---|
| 2019-05 | 0 | 1 |
| 2022-06 | 0 | 1 |
| 2025-05 | 0 | 1 |
| 2025-10 | 0 | 1 |
| 2025-12 | 0 | 2 |
Regulatory clearances
- None linked in the loaded window.
Manufacturer compliance record — HYPHEN BIOMED
- Warning Letter 2012-09-05 Hyphen BioMed sasu
- OAI 2014-02-13 Hyphen BioMed sasu · 0 citations
- OAI 2012-06-20 Hyphen BioMed sasu · 5 citations