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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
2011-03-21Z-2108-2011TerminatedPotential for false negatives test results and negative/faint positive controls—clearance family
2011-03-21Z-2109-2011TerminatedPotential for false negatives test results and negative/faint positive controls—clearance family
2011-03-21Z-2110-2011TerminatedPotential for false negatives test results and negative/faint positive controls—clearance family
2011-03-21Z-2111-2011TerminatedPotential for false negatives test results and negative/faint positive controls—clearance family
Regulatory clearances

None linked.

Manufacturer compliance record
DateTypeOutcomeFacilityCitations
2016-11-03NAINo action indicatedJant Pharmacal Corporation0
2016-11-03NAINo action indicatedJant Pharmacal Corporation0
2014-10-15NAINo action indicatedJant Pharmacal Corporation0
2014-10-15NAINo action indicatedJant Pharmacal Corporation0
2011-11-08NAINo action indicatedJant Pharmacal Corporation0
2011-11-08NAINo action indicatedJant Pharmacal Corporation0
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