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Affymetrix Inc recalls CytoScan¿ Dx Assay. The CytoScan Dx Assay consists of five reagent modules, wash buffers (WS), a microarray kit, and ana
Recalled June 8, 2016 · FDA recall Z-1909-2016 · Affymetrix
Hazard
During a recent Ohio site inspection by the FDA it was discovered that warning statements needed to be included with the product shipment. · FDA Class III
Units
507 kits
Sold at
Distributed in the US to the states of AR, CA, DC, MI, MA, MN, NC, NM, NY, PA, SC, TN, TX, WA and WV.
Description
During a recent Ohio site inspection by the FDA it was discovered that warning statements needed to be included with the product shipment.
Product
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
Manufacturer(s)
Affymetrix Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →