Lipase NG

SENTINEL CH. SPA · Model B82715 · UDI-DI 08058056681782

CHI Prescription

510(k) clearances

Adverse events

Recalls

Facilities

Description

The Lipase NG assay is an in vitro diagnostic test used for the determination on AU480 and AU680 automatic analyzers of the lipase activity in serum and plasma by kinetic colorimetric method. The assay is intended for professional use only.

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 slides are used. Falsel
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 analyzer.
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 concentration could b
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 specifications for lot-t

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.