Home › Device types › CHH
Enzymatic Esterase--Oxidase, Cholesterol
FDA product code CHH · Class 1 · Clinical Chemistry
176
Registered devices
105
Adverse events
23
Recalls
230
510(k) clearances
Devices with this code
CURO L5 TC test strip — OSANG HEALTHCARE Co., Ltd.CURO L5 Total Cholesterol Strips — KPI HEALTHCARE, INC.ABX PENTRA CHOLESTEROL CP — HORIBA ABX SASLipid Panel, 15ct., CCPlus Home — POLYMER TECHNOLOGY SYSTEMS, INC.CardioChek® PA Professional Analyzer, Refurbished — POLYMER TECHNOLOGY SYSTEMS, INC.Chemcard Cholesterol — CHEMATICS, INC.Alere Cholestech LDX® — Alere San Diego, Inc.Accutrend Plus Cholesterol strips — Roche Diagnostics GmbHAlere Cholestech LDX® — Alere San Diego, Inc.XPER Technology Procheck Witty Procheck Smart Total Cholesterol Test Strips — TAIDOC TECHNOLOGY CORPORATIONCholesterol — HORIBA INSTRUMENTS INCORPORATEDSynermed® — INFRARED LABORATORY SYSTEMS LLCDimension Vista® Flex® reagent cartridge CHOL — Siemens Healthcare Diagnostics Inc.CURO L5 Meter — OSANG HEALTHCARE Co., Ltd.CardioChek — HENRY SCHEIN, INC.Cholesterol Gen.2 — Roche Diagnostics GmbHBIOBASE — Biobase Biodustry(Shandong)Co., Ltd.CAROLINA LIQUID CHEMISTRIES CORP.® CHOLESTEROL REAGENT KIT AU-211 — CAROLINA LIQUID CHEMISTRIES CORPORATIONCURO L7 Lipid Test Strip - Lipid Profile — SD Biosensor, Inc.Cholesterol Gen.2 — Roche Diagnostics GmbHCholestech LDX™ — Alere San Diego, Inc.Teco Diagnostics Cholesterol Reagent Set — TECO DIAGNOSTICSCardioChek® Plus Professional Analyzer, Refurbished — POLYMER TECHNOLOGY SYSTEMS, INC.CURO L7 Analyzer — SD Biosensor, Inc.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-04-02 | DFI Co., Ltd. | The devices were distributed without required FDA premarket clearance or approval. |
| 2022-06-22 | Randox Laboratories Ltd. | Product fails to meet the performance claims quoted on the kit insert: Manual Procedure when calibrating using the standard provided in the kit, the change in a |
| 2021-11-10 | Beckman Coulter Inc. | Cholesterol Reagent may fail with Out of Calibration Range Low (OCR Low) and/or Back to Back (B/B) errors. Low quality control recovery failures may be observed |
| 2021-11-01 | Randox Laboratories Ltd. | When calibrating using the standard provided in the kit, the change in absorbance is lower than expected generating internal quality control results high outsid |
| 2019-06-07 | Polymer Technology Systems, Inc. | The MEMo chips provided with lot P901 may be mislabeled, the MEMo Chip may display Q901 on the analyzer LCD screen, instead of P901 |
| 2019-06-07 | Polymer Technology Systems, Inc. | The MEMo chips provided with lot P901 may be mislabeled, the MEMo Chip may display Q901 on the analyzer LCD screen, instead of P901 |
| 2019-01-16 | Polymer Technology Systems, Inc. | Some lots of test strips do not fit tightly into the optical block, and may fall out during analysis, which could lead to an incorrect result being displayed. |
| 2019-01-16 | Polymer Technology Systems, Inc. | Some lots of test strips do not fit tightly into the optical block, and may fall out during analysis, which could lead to an incorrect result being di P832 Chem |
| 2017-04-03 | Beckman Coulter Inc. | Beckman Coulter has identified the following drugs as potential sources of interference: Metamizole (Dipyrone), Sulfasalazine, and Sulfapyridine and may result |
| 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 |
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