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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
2015-03-25Z-1703-2015Class IITerminatedRecovery for assayed controls are out of assigned ranges. A drift >3 seconds in the normal APTT range and/or >15% in the pathological range has been observed. Patient samples with recoveries close to the medical decision points could exhibit a deviation up to 4 seconds for the normal range and up to 33% for the pathological range.Distribution: Worldwide Distribution. US naionwide including Puerto Rico, Barbados and Mexico.27501clearance family
Regulatory clearances

None linked.

Manufacturer compliance record
DateTypeOutcomeFacilityCitations
2026-02-26NAINo action indicatedSiemens Healthcare Diagnostics Products Ltd.0
2013-01-24NAINo action indicatedSiemens Healthcare Diagnostics Products GmbH0
2010-07-01NAINo action indicatedSiemens Healthcare Diagnostics Products Ltd.0
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