Urinary Homocystine (nonquantitative) Test System

cobas HCYS, Homocysteine Enzymatic Assay, Material Number REF 06542921190, for use on cobas c 701/702, in vitro test for total L-homocysteine

Abnormal calibration signals and control recovery issues on the Homocysteine Enzymatic (HCYS) Assay can produce erroneous patient results (positive or negative bias)

Axis-Shield Liquid Stable (LS) 2-Part HOMOCYSTEINE REAGENT; 100 test format, 1000 test format, and 200 test format; and Private Label: (Distributed by BECKMAN C

Deterioration in performance of the Liquid Stable (LS) 2-Part HOMOCYSTEINE REAGENT resulting in under recovery.

Homocysteine test system - Homocysteine Reagent.

Customers complained about under-recovery of non-Roche controls and discrepant low patient results with certain Homocysteine reagent lots. This negative bias could, in the worst case, lead to inaccurately low Homocysteine results. An elevated level of Homocysteine is considered an important risk factor in the assessment of peripheral vascular disease. Falsely low values could lead to a delay of di

ADVIA Centaur HCY Diluent - 10mL Bottle Catalog number 09877493 (124533), SMN 10310370, and Ancillary Pack Catalog number 03302138 (124581), SMN 10378677. Use

ADVIA Centaur Homocysteine dilution recovery on the diluent identified the percent recovery for the 1:10 patient sample dilutions lower than reported in the Instructions for Use (IFU).

Siemens Dimension Vista Homocysteine Flex Reagent Cartridge

Dimension Vista HCYS lot 13064MA shows erratic recovery of QC and patient samples.

VITROS Chemistry Products-HCY Reagent packaged in a kit carton. Catalog# 6802002.

The firm is recalling the specific lot due to lower than expected results.

Siemens Dimension Vista(R) Homocysteine Flex(R) Reagent Cartridge

Cartridges are leaking. The leaking is observed when opening the wrapper that holds the reagent cartridge.

Homogeneous Enzymic Homocysteine Reagent Two Part Reagent Method. Catalog Number E02-057-02.

Homogeneous Enzymic Homocysteine Reagent Two Part Reagent Method will not calibrate due to Reagent R1 had prematurely decayed.

Homocysteine Reagent Test Kit. The Homocysteine test kits were manufactured under 2 brand names. The first brand name Catch, the label reads "CATCH Catch Inc

A high homocysteine level can be reported as falsely low.

AxSYM Homocysteine Reagent Pack, list 5F51-20, Produced by Axis-Shield, Oslo, Norway, for Abbott Laboratories, Abbott Park, IL 60064 USA

There is a kit-to-kit difference within the lots, with the reagents generating different polarization values than those in others.