Affymetrix Inc recalls CytoScan¿ Dx Assay. The CytoScan Dx Assay consists of five reagent modules, wash buffers (WS), a microarray kit, and an…

Recall date

April 14, 2016

Source

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

Recall number

Z-1909-2016

FDA classification

Class III

Brand / firm

Affymetrix Inc

Sold / distributed

Distributed in the US to the states of AR, CA, DC, MI, MA, MN, NC, NM, NY, PA, SC, TN, TX, WA and WV.

Why it was recalled

During a recent Ohio site inspection by the FDA it was discovered that warning statements needed to be included with the product shipment.

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

CytoScan¿ Dx Assay. The CytoScan Dx Assay consists of five reagent modules, wash buffers (WS), a microarray kit, and analysis software. The CytoScan Dx Assay consists of five reagent modules, wash buffers (WS), a microarray kit, and analysis software: MOD R LA, CytoScan¿ Dx Pre-PCR (-20¿C) MOD T E W, CytoScan¿ Dx Pre-PCR (2¿-8¿C) MOD F L H, CytoScan¿ Dx Post-PCR (-20¿C) MOD S AH W PB, CytoScan¿ Dx Post-PCR (2¿-8¿C) MOD E PW, CytoScan¿ Dx Post-PCR (15¿- 30¿ C) CytoScan Dx WS A CytoScan Dx WS B CytoScan¿ Dx Array kit, 6Pk ChAS Dx Analysis Software and Browser