U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
During a recent ohio site inspection by the fda it was discovered that warning statements needed to be included with the product shipment.
조치
A letter dated April 14, 2016 was sent to customers. The letter stated the reason for the recall. It also informed customers that there is no impact on the performance of the assay. Customers were asked to either visit the IVD web portal (www.affymetrix.com/ivd) and review the warning statements; or, request a hard copy free of charge.
Distributed in the US to the states of AR, CA, DC, MI, MA, MN, NC, NM, NY, PA, SC, TN, TX, WA and WV.
제품 설명
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