MedtestDx, Inc. recalls MedTest DX Control Reconstitution Fluid Kit configuration: 20 x 5 ml. Bottle: 5 ml amber glass Cap: 18 mm white seal pl…

Recall date

May 15, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2768-2015

FDA classification

Class II

Brand / firm

MedtestDx, Inc.

Sold / distributed

US Nationwide Distribution.

Why it was recalled

Vial to vial variation in the fill volume that could affect control recovery issues and cause a control result to fall outside the suggested recovery ranges. An under-fill of the vials was found ranging as low as 4.63 ml. When used to reconstitute HNC/HEC, control values were shown to be out of range running on the high end.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

MedTest DX Control Reconstitution Fluid Kit configuration: 20 x 5 ml. Bottle: 5 ml amber glass Cap: 18 mm white seal plug seal rubber HC-DIL (Human Control Diluent) is reagent grade water filled into 5ml vials used to reconstitute Human controls HNC200 and HEC200. in vitro diagnostic.