Urinary Homocystine (Nonquantitative) Test System（LPS）

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

Homocysteine Reagent, Calibration Failures and Quality Control Recovery Issues on cobas c 701 and 702 modules

There is a potential performance issue as detected by an under-recovery of sample results during routine testing.

There is a potential performance issue as detected by an under-recovery of sample results during routine testing.

There is a potential performance issue as detected by an under-recovery of sample results during routine testing.

The firm confirmed a reduced once-opened and on-board stability for N Latex Homocysteine (HCY) OPAX03 lot 802907632 that may result in erroneously reduced or elevated homocysteine values. The stability issue may lead to higher than expected lot-to-lot variation and an impaired product performance.

Reagent lots # 15243MA and 15243MB shows a reduced stability once opened that does not meet the Instructions For Use claim of seven (7) days. A maximum bias of -37% was observed.

Deterioration in performance of the Liquid Stable (LS) 2-Part HOMOCYSTEINE REAGENT resulting in under recovery. The manufacturer has indicated that the HOMOCYSTEINE REAGENT lot listed above shows deterioration in assay performance manifesting itself by under recovery of Homocysteine in Controls and Patient Samples. The cause of this deterioration has been attributed to a loss of reductant activity in Reagent 1. Testing performed indicated that the affected lot is at the limit of acceptable clinical performance. This observation was consistent across the reportable range of the assay. For this reason, do not continue to use affected reagent lot. Test data generated to date will be acceptable where validity control specifiCations have been met.

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

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

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

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).

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

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