Home › Device types › CHI
Lipase-Esterase, Enzymatic, Photometric, Lipase
FDA product code CHI · Class 1 · Clinical Chemistry
47
Registered devices
93
Adverse events
22
Recalls
20
510(k) clearances
Devices with this code
LIPASE (LPS) — RANDOX LABORATORIES LIMITEDCAROLINA LIQUID CHEMISTRIES CORP.® LIPASE REAGENT KIT ST621 — CAROLINA LIQUID CHEMISTRIES CORPORATIONLipase colorimetric assay — Roche Diagnostics GmbHBIOBASE — Biobase Biodustry(Shandong)Co., Ltd.Dimension Lipase (LIP) Flex reagent cartridge — Siemens Healthcare Diagnostics Inc.LIPASE (LPS) — RANDOX LABORATORIES LIMITEDABX PENTRA LIPASE CP — HORIBA ABX SASYumizen C1200 Lipase — HORIBA ABX SASMedTest Dx, Inc. Lipase (Colorimetric) — Medtest Dx, Inc.BIOBASE — Biobase Biodustry(Shandong)Co., Ltd.Lipase NG — SENTINEL CH. SPAVITROS — ORTHO-CLINICAL DIAGNOSTICS, INC.CAROLINA LIQUID CHEMISTRIES CORP.® LIPASE REAGENT KIT AU-621 — CAROLINA LIQUID CHEMISTRIES CORPORATIONBIOBASE — Biobase Biodustry(Shandong)Co., Ltd.Pointe Scientific, Inc. Lipase-Color — HORIBA INSTRUMENTS INCORPORATEDDimension Vista® Flex® reagent cartridge LIPL — Siemens Healthcare Diagnostics Inc.Synchron — Beckman Coulter, Inc.CAROLINA LIQUID CHEMISTRIES CORP.® LIPASE REAGENT KIT DT621 — CAROLINA LIQUID CHEMISTRIES CORPORATIONPointe Scientific, Inc. Lipase Standard — HORIBA INSTRUMENTS INCORPORATEDPointe Scientific, Inc. Lipase-Color — HORIBA INSTRUMENTS INCORPORATEDACE — ALFA WASSERMANN, INC.Dimension® Flex® reagent cartridge LIPL — Siemens Healthcare Diagnostics Inc.BIOBASE — Biobase Biodustry(Shandong)Co., Ltd.BIOBASE — Biobase Biodustry(Shandong)Co., Ltd.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2023-09-12 | Ortho-Clinical Diagnostics, INc. | Products 1668409 and 8297749 may contain VITROS Lipase Slides with an abnormality which could cause -46% to +86% bias in lipase results depending on how the sli |
| 2020-06-26 | RANDOX LABORATORIES, LTD. | Randox have confirmed imprecision of quality control and patient samples when using specific Randox Lipase buffer batches. |
| 2020-06-26 | RANDOX LABORATORIES, LTD. | Randox have confirmed imprecision of quality control and patient samples when using specific Randox Lipase R2 Substrate batches. |
| 2020-06-26 | RANDOX LABORATORIES, LTD. | Randox have confirmed imprecision of quality control and patient samples when using specific Randox Lipase reagent batches. |
| 2019-12-20 | Siemens Healthcare Diagnostics, Inc. | Firm has received customer complaints regarding failed calibrations and increased imprecision of quality control and patient samples when using this product. |
| 2019-02-06 | Medica Corporation | Wash1 solution is ineffective in cleaning dispensing probe of TRIG and LDL reagents that interfere with the Lipase (LIP) assay on the EasyRA clinical chemistry |
| 2018-10-30 | Horiba Instruments Incorporated | Potential for chemical analyzer to report abnormal results due to an interference with triglycerides CP and Cholesterol CP. An over estimation of the lipase c |
| 2018-09-07 | Siemens Healthcare Diagnostics, Inc. | There is lot to lot variability for QC and patient results when using the identified reagent cartridge lots. |
| 2018-09-07 | Siemens Healthcare Diagnostics, Inc. | There is lot to lot variability for QC and patient results when using the identified reagent cartridge lots. |
| 2017-12-14 | Siemens Healthcare Diagnostics, Inc. | Calibration failure - confirmed a positive bias with LIPL lot FB8109 when compared to other Dimension LIPL lots. Lot FB8109 is not meeting Siemens internal spec |
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