Home › Device types › LBR
Ldl & Vldl Precipitation, Hdl
FDA product code LBR · Class 1 · Clinical Chemistry
110
Registered devices
26
Adverse events
11
Recalls
66
510(k) clearances
Devices with this code
Pointe Scientific, Inc. — HORIBA INSTRUMENTS INCORPORATEDCURO L5 Total Cholesterol Strips — KPI HEALTHCARE, INC.Pointe Scientific, Inc. — HORIBA INSTRUMENTS INCORPORATEDTeco Diagnostics HDL Cholesterol Reagent Set — TECO DIAGNOSTICSPointe Scientific, Inc. autoHDL Cholesterol — HORIBA INSTRUMENTS INCORPORATEDLipid Panel, 15ct., CCPlus Home — POLYMER TECHNOLOGY SYSTEMS, INC.CardioChek® PA Professional Analyzer, Refurbished — POLYMER TECHNOLOGY SYSTEMS, INC.MedTest DX autoHD™L / BS480 — Medtest Dx, Inc.CardioChek — HENRY SCHEIN, INC.L-Type HDL-C Reagent 1 — FUJIFILM WAKO PURE CHEMICAL CORPORATIONCURO L7 Lipid Test Strip - Lipid Profile — SD Biosensor, Inc.LDL-Cholesterol Gen.3 — Roche Diagnostics GmbHPointe Scientific, Inc. — HORIBA INSTRUMENTS INCORPORATEDN-geneous LDL Cholesterol Reagent (R1) — SEKISUI DIAGNOSTICS, LLCTeco Diagnostics Direct HDL Cholesterol Reagent Set — TECO DIAGNOSTICSCardioChek® Plus Professional Analyzer, Refurbished — POLYMER TECHNOLOGY SYSTEMS, INC.CURO L7 Analyzer — SD Biosensor, Inc.CAROLINA LIQUID CHEMISTRIES CORP.® HDL RGT. KIT BL-616 — CAROLINA LIQUID CHEMISTRIES CORPORATIONPointe Scientific — HORIBA INSTRUMENTS INCORPORATEDN-geneous LDL Cholesterol Reagent (R2) — SEKISUI DIAGNOSTICS, LLCPTS Panels® HDL Cholesterol Test Strips — POLYMER TECHNOLOGY SYSTEMS, INC.CAROLINA LIQUID CHEMISTRIES CORP.® HDL DIRECT CC615 — CAROLINA LIQUID CHEMISTRIES CORPORATIONPointe Scientific, Inc. — HORIBA INSTRUMENTS INCORPORATEDSTANDARD™ LipidoCare Lipid Test Strip - Lipid Profile — SD Biosensor, Inc.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2018-08-10 | Medtest Holdings, Inc. | Vials of the autoHDL/LDL Calibrator were shipped without a vial label. |
| 2016-07-20 | Sterling Diagnostics, Inc. | 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 k |
| 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 |
| 2015-03-13 | Pointe Scientific, Inc. | 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 performan |
| 2009-11-10 | Pointe Scientific, Inc. | The firm initiated the recall due to the presence of visible contamination of the product. |
| 2009-11-10 | Pointe Scientific, Inc. | The firm initiated the recall due to the presence of visible contamination of the product. |
| 2009-01-29 | Pointe Scientific, Inc. | The R1 reagent has microbial contamination. |
| 2009-01-29 | Pointe Scientific, Inc. | The R1 reagent has microbial contamination. |
| 2006-09-18 | Stanbio Laboratory, Inc | Unexpected changes in QC and proficiency results due to QC and proficiency material matrix. |
| 2006-09-18 | Stanbio Laboratory, Inc | Unexpected changes in QC and proficiency results due to QC and proficiency material matrix. |
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