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Adverse-event reports (MAUDE)

Read this first: 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 shows reporting volume for the average device in the same FDA product code — a reporting baseline, not a risk measure.

No adverse-event reports are linked to this device.

Recall history
InitiatedRecall #ClassStatusReasonQuantityLink basis
2023-02-01Z-1227-2023Class IIOpen, ClassifiedNew 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 fertilityDistribution: US Nationwide distribution in the state of NC.2 unitsclearance family
Regulatory clearances

None linked.

Manufacturer compliance record
DateTypeOutcomeFacilityCitations
2014-02-13OAIOfficial action indicatedHyphen BioMed sasu0
2012-09-05WLWarning LetterHyphen BioMed sasu—
2012-06-20OAIOfficial action indicatedHyphen BioMed sasu5
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