Lipase-esterase, Enzymatic, Photometric, Lipase

VITROS Chemistry Products Lipase Slides, Product Codes 1668409 (contains 60 Slides per Cartridge) and 8297749 (contains 18 slides per cartridge)

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. Falsely low levels could result in a missed or delayed diagnosis of acute pancreatitis and may lead to diagnostic confusion in the setting of acute abdominal symptoms. Falsely elevated levels would not result in patient harm but may cause diagnostic confusion and a delay in accurate diagnosis of a patient with abdominal pain.

Randox Lipase Assay: Lipase Colorimetric Reagent - Product Usage: A Lipase test system is a device intended for the quantitative in vitro determination of Lipas

Randox have confirmed imprecision of quality control and patient samples when using specific Randox Lipase reagent batches.

Randox Lipase Assay: Lipase Colorimetric R1 Buffer - Product Usage: A Lipase test system is a device intended for the quantitative in vitro determination of Lip

Randox have confirmed imprecision of quality control and patient samples when using specific Randox Lipase buffer batches.

Randox Lipase Assay: Lipase Colorimetric R2 Substrate - Product Usage: A Lipase test system is a device intended for the quantitative in vitro determination of

Randox have confirmed imprecision of quality control and patient samples when using specific Randox Lipase R2 Substrate batches.

ADVIA Chemistry Lipase, Ref. No. 01984894

Firm has received customer complaints regarding failed calibrations and increased imprecision of quality control and patient samples when using this product.

ADVIA Chemistry Lipase Reagent , Catalog Number B01-4840-01 REF: 01984894.

Siemens internal investigation confirmed that current contamination avoidance settings do not prevent carryover resulting in falsely elevated ADVIA Chemistry Lipase outlier results when running with Triglycerides, Triglycerides_2, Triglycerides_c, Cholesterol concentrated, and DLDL reagents.

Lipase Reagent, 7D80.

Package inserts have incorrect SmartWash parameters for Triglyceride.

VITROS Chemistry Products LIPA Slides packaged as 300 slides/pack catalog number 1668409 and packaged as 90 slides/pack catalog number 8297749

Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product Slides due to slide dispense issues.

Dimension LIP Flex Reagent Cartridge, Catalog# DF55A

Open Well instability: After calibration, QC shifts high (out of range) after the Flex Well is hydrated. Shifts of up to 20% have been observed in both QC and patient samplesas soon as two hours post hydration.

Equal Diagnostics Lipase Color Reagent Kit

Calibration and Quality Control outside of established range resulting from an increase in initial OD readings with the reagent contained within the kits.