Exact Sciences Corporation recalls Exact Sciences Sample Mixer 2. For In Vitro Diagnostic Use. The Exact Sciences Sample Mixer 2 is intended for mixing st…

Recall date

April 28, 2017

Source

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

Recall number

Z-2219-2017

FDA classification

Class II

Brand / firm

Exact Sciences Corporation

Sold / distributed

US to WI only

Why it was recalled

Exact Sciences is correcting all Sample Mixer v2 Upgrade units because of incidents of Sample Mixer door damage, which has occurred when the Sample Holder opens during a run and the Sample Holder lid makes contact with the Sample Mixer door.

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

What was recalled

Exact Sciences Sample Mixer 2. For In Vitro Diagnostic Use. The Exact Sciences Sample Mixer 2 is intended for mixing stool samples in a Sample Container as part of pre-analytic sample processing for in vitro diagnostic tests