Procalcitonin Assay
Microbiology · 21 CFR 866.3215
To aid in decision making on antibiotic therapy, including antibiotic initiation and discontinuation, for inpatients or patients in the Emergency Department, with suspected or confirmed lower respiratory tract infections (LRTI) defined as community-acquired pneumonia (CAP), acute bronchitis, and acute exacerbation of Chronic Obstructive Pulmonary Disease (AECOPD).
Recent MDR events
213 adverse event reports on file
- ELECSYS BRAHMS PCTMar 30, 2026MalfunctionRoche Diagnostics1823260-2026-01165
- ELECSYS BRAHMS PCTMar 11, 2026MalfunctionRoche Diagnostics1823260-2026-00863
- ELECSYS BRAHMS PCTJan 2, 2026MalfunctionRoche Diagnostics1823260-2026-00002
- VIDAS® B¿R¿A¿H¿M¿S PCT¿Aug 28, 2025MalfunctionBiomérieux Sa8020790-2025-00012
- VIDAS® B¿R¿A¿H¿M¿S PCT¿Aug 5, 2025MalfunctionBiomérieux Sa8020790-2025-00011
- ELECSYS BRAHMS PCTJul 30, 2025MalfunctionRoche Diagnostics1823260-2025-02340
- ELECSYS BRAHMS PCTJun 13, 2025MalfunctionRoche Diagnostics1823260-2025-01823
- VIDAS® BRAHMS PROCALCITONINJun 12, 2025MalfunctionBiomerieux Sa8020790-2025-00009
- VIDAS® BRAHMS PROCALCITONINJun 12, 2025MalfunctionBiomerieux Sa8020790-2025-00010
- VIDAS® B·R·A·H·M·S PCT ¿Dec 13, 2024MalfunctionBiomérieux Sa8020790-2024-00016
Event type breakdown
Most-reported manufacturers
Recalls
1 recall events for this product code
Registered firms
13 firms currently registered for this product code
Diasorin Italia S.p.a.
SALUGGIA Vercelli, IT
Abbott Laboratories
Lake Forest, IL, US
Abbott Ireland
SLIGO, IE
Epitope Diagnostics, Inc.
SAN DIEGO, CA, US
Fisher Diagnostics
MIDDLETOWN, VA, US
B.r.a.h.m.s Gmbh
HENNIGSDORF Brandenburg, DE
Cezanne Sas
NIMES Gard, FR
Roche Diagnostics Gmbh
MANNHEIM Baden-Wurttemberg, DE
Siemens Healthcare Diagnostics Inc.
NEWARK, DE, US
Abbott Gmbh
Wiesbaden Hesse, DE
Fujirebio Inc.
Sagamihara-shi Kanagawa, JP
Biomerieux Sa
MARCY L ETOILE Rhone, FR
510(k) clearances
8 clearances for this product code
- Siemens Healthcare Diagnostics, Inc.Aug 26, 2022
K220262 · Dimension EXL LOCI BRAHMS Procalcitonin (PCT)
- Roche DiagnosticsMar 9, 2020
K192815 · Elecsys BRAHMS PCT
- Roche DiagnosticsJul 6, 2018
K173927 · Elecsys BRAHMS PCT
- DiaSorin, Inc.Feb 27, 2018
K173683 · LIAISON BRAHMS PCT II GEN, LIAISON Control BRAHMS PCT II GEN, LIAISON BRAHMS PCT II GEN Verifiers
- Fujirebio Diagnostics,Inc.Dec 10, 2017
K172713 · Lumipulse G BRAHMS PCT Immunoreaction Cartridges, Lumipulse G BRAHMS PCT Calibrators set
- Fisher DiagnosticsJun 1, 2017
K170652 · ARCHITECT B.R.A.H.M.S PCT, ARCHITECT B.R.A.H.M.S PCT Calibrators, ARCHITECT B.R.A.H.M.S PCT Controls
- Brahms GmbHMay 31, 2017
K171338 · B R A H M S PCT sensitive KRYPTOR
- bioMerieux, Inc.Feb 23, 2017
K162827 · VIDAS B.R.A.H.M.S. PCT (PCT)