Ldl & Vldl Precipitation, Hdl
Clinical Chemistry · 21 CFR 862.1475
Recent MDR events
26 adverse event reports on file
- LDL-CHOLESTEROL GEN.3Jun 17, 2026MalfunctionRoche Diagnostics1823260-2026-02392
- LDL-CHOLESTEROL GEN.3Jun 8, 2026MalfunctionRoche Diagnostics1823260-2026-02244
- LDL-CHOLESTEROL GEN.3May 11, 2026MalfunctionRoche Diagnostics1823260-2026-01846
- LDL-CHOLESTEROL GEN.3Apr 1, 2026MalfunctionRoche Diagnostics1823260-2026-01213
- LDL-CHOLESTEROL GEN.3Nov 26, 2025MalfunctionRoche Diagnostics1823260-2025-04860
- LDL-CHOLESTEROL GEN.3Nov 25, 2025MalfunctionRoche Diagnostics1823260-2025-04821
- LDL-CHOLESTEROL GEN.3Oct 29, 2025MalfunctionRoche Diagnostics1823260-2025-04414
- COBAS C 503 ANALYTICAL UNITOct 6, 2025MalfunctionRoche Diagnostics1823260-2025-04065
- LDL-CHOLESTEROL GEN.3Aug 14, 2025MalfunctionRoche Diagnostics1823260-2025-02487
- LDL-CHOLESTEROL GEN.3Feb 21, 2025MalfunctionRoche Diagnostics1823260-2025-00515
Event type breakdown
Recalls
11 recall events for this product code
- Sterling Diagnostics, Inc.TerminatedDec 29, 2016
Sterling Diagnostics, Inc., HDL Cholesterol (PEF Method) for IN VITRO DIAGNOSTIC USE in the quantitative determination of analytes. These are CONSUMABLES - a cu
Sterling Diagnostics, Inc. initiated a recall on 7/20/2016 for multiple diagnostic kits due to a recision of the previously extended expiration dates for the kits.
Z-0930-2017 · View FDA record ↗ - Pointe Scientific, Inc.TerminatedSep 14, 2015
Pointe Scientific autoHDL Reagent H7545
Crystals may be observed in the R1 reagent. Crystals may be a result of the reagent being frozen during transport. The crystals do not impact product performance.
Z-2764-2015 · View FDA record ↗ - Roche Diagnostics Operations, Inc.TerminatedJun 27, 2015
LDL-Cholesterol plus gen.2.
Possible drug interference when using the Trinder reaction method on multiple Cobas Analyzers. Results of Trinder tests may be falsely decreased when the tests are run with urine samples (Creatinine plus and Uric Acid applications only) or blood samples collected before sufficient time has lapsed after the administration of the drugs Acetaminophen and N-acetylcysteine.
Z-1928-2015 · View FDA record ↗ - Pointe Scientific, Inc.TerminatedFeb 25, 2010
Liquid HDL (PEG) Cholesterol Reagent Set. Pointe Scientific HDL Cholesterol Reagent Set, Pointe Scientific, Inc, Canton, MI; Catalog # H7511-60 and Catalog # H
The firm initiated the recall due to the presence of visible contamination of the product.
Z-0859-2010 · View FDA record ↗ - Pointe Scientific, Inc.TerminatedFeb 25, 2010
Liquid HDL (PEG) Cholesterol Reagent, Pointe Scientific, Inc, Canton, MI; Catalog # 7-H7511-30, 8-H7511-30, 3-H-7511-L. (Clinical chemistry).
The firm initiated the recall due to the presence of visible contamination of the product.
Z-0860-2010 · View FDA record ↗ - Pointe Scientific, Inc.TerminatedApr 27, 2009
Pointe Scientific Liquid Auto HDL Cholesterol Reagent Set, Pointe Scientific, Inc., Canton, MI, Catalog Numbers: 10-H7545-80, 12-H7545-162, 3-H7545-L, 7-H7545-
The R1 reagent has microbial contamination.
Z-1200-2009 · View FDA record ↗ - Pointe Scientific, Inc.TerminatedApr 27, 2009
Pointe Scientific Liquid Auto HDL Cholesterol Reagent Set, Pointe Scientific, Inc., Canton, MI, Catalog Numbers: 10-H7545-80, 12-H7545-162, 3-H7545-L, 7-H7545-
The R1 reagent has microbial contamination.
Z-1201-2009 · View FDA record ↗ - Stanbio Laboratory, IncTerminatedNov 14, 2006
Stanbio Laboratory Direct HDL Cholesterol LiquiColor, Catalog #0590-040; test kit contains 1/30mL container of Direct HDL-Cholesterol Buffer (R1) and 1/10mL con
Unexpected changes in QC and proficiency results due to QC and proficiency material matrix.
Z-0074-2007 · View FDA record ↗ - Stanbio Laboratory, IncTerminatedNov 14, 2006
Stanbio Laboratory Direct HDL Cholesterol LiquiColor, Catalog #0590-080; test kit contains 2/30mL container of Direct HDL-Cholesterol Buffer (R1) and 2/10mL con
Unexpected changes in QC and proficiency results due to QC and proficiency material matrix.
Z-0075-2007 · View FDA record ↗ - Stanbio Laboratory, IncTerminatedNov 14, 2006
Stanbio Laboratory SIRRUS Direct HDL Cholesterol LiquiColor, Catalog #S0590-540; kit contains 6 x 90 tests, HDL Buffer (R1) and HDL Enzyme (R2); in vitro diagno
Unexpected changes in QC and proficiency results due to QC and proficiency material matrix.
Z-0076-2007 · View FDA record ↗
Registered firms
61 firms currently registered for this product code
Abbott Diagnostics Technologies As
Oslo, NO
Infrared Laboratory Systems Dba Synermed
WESTFIELD, IN, US
Acon Biotech (hangzhou) Co., Ltd.
HANGZHOU Zhejiang, CN
Diazyme Laboratories, Inc.
POWAY, CA, US
Teco Diagnostics
ANAHEIM, CA, US
Polymer Technology Systems
Whitestown, IN, US
Roche Diagnostics Gmbh
MANNHEIM Baden-Wurttemberg, DE
Horiba Instruments Incorporated
Canton, MI, US
Sanzay Corporation -
Miami Gardens, FL, US
Urit Medical Electronic Co., Ltd.
Guilin Guangxi, CN
Sd Biosensor, Inc.
Cheongju-si Chungbuk, KR
East West Wisconsin
WHITEWATER, WI, US
Jant Pharmacal Corp.
ENCINO, CA, US
Osang Llc
S Pasadena, CA, US
Sekisui Medical Co., Ltd. Tsukuba Plant
Ryugasaki-shi Ibaraki, JP
Ortho Clinical Diagnostics, K.k.
Harumi, Chuo-ku Tokyo, JP
Ortho-clinical Diagnostics, Inc.
Rochester, NY, US
Hangzhou Lysun Biotechnology Co.ltd
Hangzhou Zhejiang, CN
510(k) clearances
66 clearances for this product code
- Roche Diagnostics Operations (Rdo)Jan 28, 2015
K143691 · LDLC3 LDL-Cholesterol Gen.3
- General AtomicsJan 22, 2008
K072523 · DIAZYME LDL-CHOLESTEROL REAGENT, CALIBRATOR AND CONTROLS
- Teco DiagnosticsJul 26, 2005
K050823 · DIRECT HDL CHOLESTEROL AND DIRECT HDL/LDL CALIBRATOR
- Hemagen Diagnostics, Inc.Dec 24, 2002
K023784 · RAICHEM HDL CHOLESTEROL USING CANTROL HDL PRECIPITATING TUBES ON THE COBAS MIRA ANAYLZER
- Ortho-Clinical Diagnostics, Inc.Aug 30, 2001
K012593 · VITROS CHEMISTRY PRODUCTS MAGNETIC HDL-CHOLESTEROL REAGENT, VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 2
- Elan DiagnosticsAug 12, 1999
K992029 · ATAC DIRECT HDL CHOLESTEROL REAGENT AND ATAC HDL-C CALIBRATOR KITS
- Pointe Scientific, Inc.,Aug 5, 1999
K992002 · AUTOHDL CHOLESTEROL REAGENT SET
- Elan Holdings, Inc.Jul 9, 1999
K991789 · ATAC-PAK DIRECT HDL CHOLESTEROL REAGENT AND ATAC HDL-C CALIBRATOR KITS