Plasma, Coagulation Control

5-PLASMA Bivalirudin Control, Model Number 5D-44905

Stability issues with the reconstituted lyophilized human plasma and bivalirudin matrix have been identified. These stability issues lead to a degradation of measurable bivalirudin in the controls, calibrators, and linearity values.

directCHECK ACT-LR whole blood quality control, level 2

Assayed Whole blood control contains labeling with incorrect performance range.

STA SYSTEM CONROL N + P (ref. 00678)

A positive bias was confirmed to exists on the STA - Unicalibrator levels with STA - Deficient IX and STA - Deficient VIII when compared to the International Standard (IS) for factor VIII or IX. This bias is also observed on several External Quality Assessment (EQA) results.

HemosIL Normal Control 1 UNASSAYED

HemosIL Low, Abnormal, Normal Controls UNASSAYED (no-value assigned) lacks 510(k) approval

HemosIL Low Abnormal Control 2 UNASSAYED

HemosIL Low, Abnormal, Normal Controls UNASSAYED (no-value assigned) lacks 510(k) approval

HemosIL High Abnormal Control 3 UNASSAYED

HemosIL Low, Abnormal, Normal Controls UNASSAYED (no-value assigned) lacks 510(k) approval

STA - System Control N + P

Factor VIII quality control results are being recovered below the assigned ranges for STA System Control N+P.

International Technidyne Corporation (ITC) directCheck Whole Blood Quality Controls Plasma, Coagulation Control. Catalog number: DCJLR-N; in vitro diagnostic

The package insert for the directCheck Microcoagulation Quality Control contains an incorrect acceptable performance range regarding ACT-LR cuvettes

GEM Check Coag CNTRL Normal APTT Whole Blood Controls Package Insert:

Certain lots of GEM Check Coag Whole Blood Controls contain an error in the package insert where the incorrect Acceptable Performance Ranges were published.

GEM Check Coag CNTRL Abnormal APTT Whole Blood Controls Package Insert; IVD. 06260060100. 15/pk.

Certain lots of GEM Check Coag Whole Blood Controls contain an error in the package insert where the incorrect Acceptable Performance Ranges were published.