Colorimetric Method, Triglycerides
Clinical Chemistry · 21 CFR 862.1705
Recent MDR events
6 adverse event reports on file
- LIPID PROFILE GLU CASSETTEMay 18, 2026MalfunctionAlere San Diego, Inc.2027969-2026-00053
- CURO L7Feb 17, 2021InjurySd Biosensor, Inc.MW5099467
- UNICEL® DXC 600 SYNCHRON® CLINICAL SYSTEMMay 24, 2011MalfunctionBeckman Coulter, Inc.2050012-2011-01892
- ADVIA CHEMISTRY TRIGLYCERIDE METHODMay 24, 2008OtherSiemens Healthcare Diagnostics, Inc.2432235-2008-00060
- ADVIA CHEMISTRY TRIGLYCERIDE METHODMay 22, 2008OtherSiemens Healthcare Diagnostics, Inc.2432235-2008-00047
- CHOLESTECH LDXApr 11, 2001MalfunctionCholestech Corp.MW1021594
Event type breakdown
Recalls
2 recall events for this product code
- Mckesson Medical-Surgical Inc. Corporate OfficeOpen, ClassifiedMay 27, 2025
ABBOTT RAPID DX N AMERICA LLC, TEST CHOLESTEC LDXLIPID PROFILE (10/BX 50BX/CS) CASSETTES.
transit delays of certain cold chain products due to severe thunderstorms which may caused the products to be stored outside the recommended labeled storage conditions. This failure could increase the probability of an incorrect test result or a delayed test result.
Z-1825-2025 · View FDA record ↗ - Mckesson Medical-Surgical Inc. Corporate OfficeOpen, ClassifiedMay 27, 2025
ABBOTT RAPID DX N AMERICA LLC CHOLESTECH LDX LIPID PROFILE+GLUCOSE (10/BX 50BX/CS) TEST.
transit delays of certain cold chain products due to severe thunderstorms which may caused the products to be stored outside the recommended labeled storage conditions. This failure could increase the probability of an incorrect test result or a delayed test result.
Z-1826-2025 · View FDA record ↗
Registered firms
35 firms currently registered for this product code
Abbott Diagnostics Technologies As
Oslo, NO
Acon Biotech (hangzhou) Co., Ltd.
HANGZHOU Zhejiang, CN
Polymer Technology Systems
Whitestown, IN, US
Abaxis, Inc.
UNION CITY, CA, US
Sd Biosensor, Inc.
Cheongju-si Chungbuk, KR
East West Wisconsin
WHITEWATER, WI, US
Nova Biomedical Corporation
WALTHAM, MA, US
Jant Pharmacal Corp.
ENCINO, CA, US
Osang Llc
S Pasadena, CA, US
Biobase Biodustry(shandong)co., Ltd
Jinan Shandong, CN
Fisher Diagnostics
MIDDLETOWN, VA, US
Osang Healthcare Co., Ltd.
ANYANG Gyeonggi, KR
Bialex Lab
Wichita Falls, TX, US
Dongguan Bao Kang Dian Zi Ke Ji Limited
Dongguan City Guangdong, CN
Wiener Laboratorios S.a.i.c.
ROSARIO Santa Fe, AR
Ixensor Co Ltd
Taipei, TW
Acon Laboratories, Inc.
SAN DIEGO, CA, US
Home Access Health Corp.
Hoffman Est, IL, US
Sd Biosensor, Inc.
Suwon-si Gyeonggi, KR
510(k) clearances
22 clearances for this product code
- Abaxis, Inc.Apr 24, 2012
K120664 · PICCOLO TRGLYCERIDES-CAPILLARY TEST SYSTEM
- Abaxis, Inc.Jan 24, 2003
K023639 · PICCOLO TRIGLYCERIDES TEST SYSTEM
- Polymer Technology Systems, Inc.Jul 3, 2000
K000586 · BIOSCANNER TRIGLYCERIDES TEST STRIPS
- Polymer Technology Systems, Inc.May 24, 2000
K991894 · BIOSCANNER TRIGLYCERIDES TEST STRIPS
- Derma Media Lab., Inc.Apr 21, 1997
K971005 · TRIGLYCERIDES
- Schiapparelli Biosystems, Inc.Oct 23, 1995
K954187 · TRIGLYCERIDES REAGENT
- Data Medical Associates, Inc.Jul 20, 1994
K941063 · DNA TRIGLYCERIDE PROCEDURE
- Instrumentation Laboratory COMar 28, 1994
K931116 · IL TEST(TM) TRIGLYCERIDE