U.v. Method, Cpk Isoenzymes
Clinical Chemistry · 21 CFR 862.1215
Recent MDR events
11 adverse event reports on file
- DJO SURGICALJul 13, 2026InjuryEncore Medical L.p.1644408-2026-01328
- DJO SURGICALMay 20, 2026InjuryEncore Medical L.p1644408-2026-00965
- JRN II BCS LCK FEM IMPLANT IMPACTJan 28, 2026MalfunctionSmith & Nephew, Inc.1020279-2026-00126
- SPECIFIC DEVICE NOT REPORTEDMay 28, 2024InjuryExactech, Inc.1038671-2024-01481
- ALL POLY TIBIA COLUMBUS CR DD T1 10MMFeb 4, 2021InjuryAesculap Ag9610612-2021-00048
- COLUMBUS UCR TIBIAL PLATEAU CEMENTED T2+Jul 24, 2015MalfunctionAesculap Ag & Co. Kg3005673311-2015-00079
- AXSYM CK-MBFeb 24, 2010MalfunctionAbbott Laboratories1628664-2010-00095
- UNKNOWN DEPUY TIBIAL INSERTSep 18, 2006InjuryDepuy Orthopaedics, Inc.1818910-2006-02717
- UNKNOWN TIBIAL INSERTSep 8, 2005InjuryDepuy Orthopaedics, Inc.1818910-2005-01675
- JET-XJun 2, 2005InjurySmith & Nephew, Inc., Othopaedic Division1020279-2005-00227
Event type breakdown
Recalls
2 recall events for this product code
- Medtest Holdings, Inc.TerminatedJun 29, 2017
The Pointe Scientific CK-MB Isoenzyme Control
Incorrect control range in product labeling
Z-2649-2017 · View FDA record ↗ - Zimmer Biomet, Inc.TerminatedUnknown
PERSONA THE PERSONALIZED KNEE SYSTEM "PSN TIB STM 5 DEG SZ D R" indicated for patients with severe knee pain and disability due to: - Rheumatoid arthritis, oste
A complaint was received for Item 42-5320-067-02, lot 63236047. It was report that there was no set screw or taper plug included in the box. Complaint investigation confirmed that the entire lot of 63236047 was missing the set screw and taper plug.
Z-1224-2018 · View FDA record ↗
Registered firms
7 firms currently registered for this product code
510(k) clearances
27 clearances for this product code
- Roche DiagnosticsMay 26, 2017
K162526 · Creatine Kinase-MB
- ElitechgroupJul 18, 2014
K141265 · ELITECH CLINICAL SYSTEMS ENVOY 500 CK REAGENT KIT
- ElitechgroupAug 22, 2012
K122083 · ELITECH CLINICAL SYSTEMS CK NAC SL
- Wiener Laboratories SaicJan 3, 2003
K023744 · WIENER LAB. CK-MB DS UV UNITEST, MODEL 28 X 2.5 ML CAT. NR. 1271354
- Roche Diagnostics Corp.Dec 18, 2000
K003158 · ROCHE DIAGNOSTICS CK-MB
- Boehringer Mannheim Corp.Jun 11, 1996
K961501 · ELECSYS CK-MB
- Miles, Inc.Mar 13, 1995
K950186 · CK-MB METHOD FOR THE TECHNICON IMMUNO 1(R) SYSTEM IN-VITRO DIAGNOSTIC SYSTEM
- Princeton BioMeditech Corp.Feb 22, 1995
K944325 · LIFESIGN, CARE POINT, VITALSIGN, ACCUSIGN