Home › Device types › MRR
System, Test, Low Density, Lipoprotein
FDA product code MRR · Class 1 · Clinical Chemistry
63
Registered devices
13
Adverse events
9
Recalls
31
510(k) clearances
Devices with this code
NMR Reference Standard — Labcorp of AmericaBIOBASE — Biobase Biodustry(Shandong)Co., Ltd.LDL Cholesterol — SEKISUI DIAGNOSTICS, LLCAtellica CH LDLC — Siemens Healthcare Diagnostics Inc.BIOBASE — Biobase Biodustry(Shandong)Co., Ltd.MedTest Dx, Inc. autoLDL — Medtest Dx, Inc.ADVIA® Chemistry Direct LDL Cholesterol Reagents — Siemens Healthcare Diagnostics Inc.DIRECT LDL-CHOLESTEROL (LDL) — RANDOX LABORATORIES LIMITEDBIOBASE — Biobase Biodustry(Shandong)Co., Ltd.Pointe autoLDL Cholesterol Reagent — HORIBA INSTRUMENTS INCORPORATEDNMR Diluent 1 — Labcorp of AmericaMercodia Oxidized LDL ELISA — Mercodia ABBIOBASE — Biobase Biodustry(Shandong)Co., Ltd.DIRECT LDL-CHOLESTEROL (LDL) — RANDOX LABORATORIES LIMITEDN-geneous LDL-ST Cholesterol Reagent (R1) — SEKISUI DIAGNOSTICS, LLCLDL — RANDOX LABORATORIES LIMITEDBIOBASE — Biobase Biodustry(Shandong)Co., Ltd.MedTest Dx, Inc. autoLDL Cholestrol — Medtest Dx, Inc.BIOBASE — Biobase Biodustry(Shandong)Co., Ltd.CAROLINA LIQUID CHEMISTRIES CORP.® LDL CHOLESTEROL DIRECT REAGENT KIT DT661 — CAROLINA LIQUID CHEMISTRIES CORPORATIONBIOBASE — Biobase Biodustry(Shandong)Co., Ltd.BIOBASE — Biobase Biodustry(Shandong)Co., Ltd.Teco Diagnostics Direct LDL Cholesterol Reagent Set — TECO DIAGNOSTICSCAROLINA LIQUID CHEMISTRIES CORP.® LDL DIRECT REAGENT CC667 — CAROLINA LIQUID CHEMISTRIES CORPORATION
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-09-17 | Beckman Coulter Inc. | Beckman Coulter has identified that there is an increased probability Synchron Systems Direct LDL Cholesterol (LDLD REF 969706) reagent lot M404166 may generate |
| 2023-01-27 | Siemens Healthcare Diagnostics, Inc. | Reagent Carryover from LDL Cholesterol Direct (DLDL), Total Protein II (TP), Triglycerides (Trig), and Triglycerides_2 (Trig_2) Impacting Magnesium (Mg) Results |
| 2018-10-08 | Ortho-Clinical Diagnostics | VITROS Chemistry Products dLDL Reagent GENs 26 and 27, negatively biased results |
| 2016-03-17 | Siemens Healthcare Diagnostics, Inc. | Siemens Healthcare Diagnostics has become aware of N-Acetylcysteine (NAC) and Metamizole (Dipyrone) interference with Trinder and Trinder-like reaction assays. |
| 2015-05-07 | Roche Diagnostics Operations, Inc. | Possible drug interference when using the Trinder reaction method on multiple Cobas Analyzers. Results of Trinder tests may be falsely decreased when the tests |
| 2008-06-11 | Roche Diagnostics Corp. | Some of the labels are glossy, resulting in the bar code being difficult to read by the bar code reader. |
| 2008-05-29 | Polymer Technology Systems, Inc. | The expiration date was extended by 20 weeks without justification. |
| 2003-08-15 | Beckman Coulter Inc | LDL Cholesterol component in controls are unstable. |
| 2003-02-10 | Beckman Coulter Inc | Expiration date on the reagent cartridges and kit box were incorrect in that they were about 6 months beyond the actual expiration date. |
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