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Terminated

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 (-20C) MOD T E W, CytoScan Dx Pre-PCR (2-8C) MOD F L H, CytoScan Dx Post-PCR (-20C) MOD S AH W PB, CytoScan Dx Post-PCR (2-8C) 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

FDA Recall Z-1909-2016 · Posted None

Recalling FirmAffymetrix Inc
Recall StatusTerminated
Product CodePFX
Date Initiated2016-04-14
Date Terminated2016-08-17
Product Quantity507 kits

Reason for Recall

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

Firm Action

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.

Root Cause

Labeling design

Distribution Pattern

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

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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