PRIClass 2
Procalcitonin Assay
FDA adverse event reports and recall history for procalcitonin assay (product code PRI), from the public MAUDE/AEMS corpus and the live FDA recall database.
- Total reports
- 213
- Deaths
- 0
- Injuries
- 3
- Malfunctions
- 209
Reports per year
118
419
320
15721
1622
1223
1124
625
326
Source: FDA adverse event reports by year received, 2018–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Recent recalls
- Open, ClassifiedNonconforming Material/Component
VIDAS B.R.A.H.M.S. PROCALCITONIN PCT, REF 30450-01
bioMerieux has been receiving an increasing number of complaints linked to a VIDAS substrate error. It prevents the test from being run, therefore leads to potential delayed results as the user must run another test.
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