Home › Device types › LBR
Ldl & Vldl Precipitation, Hdl
FDA product code LBR · Class 1 · Clinical Chemistry
112
Registered devices
26
Adverse events
11
Recalls
66
510(k) clearances
Devices with this code
Pointe Scientific, Inc. — HORIBA INSTRUMENTS INCORPORATEDMission Cholesterol Optical Check Device — Acon Laboratories, Inc.STANDARD™ LipidoCare Lipid Test Strip - Lipid Profile — SD Biosensor, Inc.LDL-Cholesterol Gen.3 — Roche Diagnostics GmbHTeco Diagnostics HDL Cholesterol Reagent Set — TECO DIAGNOSTICSPointe Scientific, Inc. — HORIBA INSTRUMENTS INCORPORATEDPTS Panels® CHOL+HDL+GLU Test Strips (10-ct) — POLYMER TECHNOLOGY SYSTEMS, INC.STANDARD™ LipidoCare Lipid Test Strip - Lipid Profile — SD Biosensor, Inc.Alinity — ABBOTT LABORATORIESPointe Scientific, Inc. — HORIBA INSTRUMENTS INCORPORATEDMission Cholesterol Test Device - 3-in-1 Lipid Panel 25T — Acon Laboratories, Inc.Assy Vial, Lipid Panel Test Strips, 1 ct, CardioChek Plus Home — POLYMER TECHNOLOGY SYSTEMS, INC.Pointe Scientific, Inc. — HORIBA INSTRUMENTS INCORPORATEDLipid + eGLU Smart Bundle™ , CC Plus Home (15-pk) — POLYMER TECHNOLOGY SYSTEMS, INC.Blood Lipid Analyzer — Urit Medical Electronic Co., Ltd.Synermed® — INFRARED LABORATORY SYSTEMS LLCYumizen C1200 HDL Direct — HORIBA ABX SASLDL-Cholesterol Gen.3 — Roche Diagnostics GmbHPointe autoHDL for the BS480 — HORIBA INSTRUMENTS INCORPORATEDL-Type HDL-C Reagent 2 — FUJIFILM WAKO PURE CHEMICAL CORPORATIONCardioChek — HENRY SCHEIN, INC.CardioChek — HENRY SCHEIN, INC.Pointe Scientific, Inc. — HORIBA INSTRUMENTS INCORPORATEDL-Type LDL-C Reagent 1 — FUJIFILM WAKO PURE CHEMICAL CORPORATION
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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