CytoScan¿ Dx Assay — Class III medical device recall Z-1909-2016

Terminated recall by Affymetrix Inc, reported 2016-06-08, distributed in AR, CA, DC, MA, MI, MN, NC, NM…. During a recent Ohio site inspection by the FDA it was discovered that warning statements needed to be include

Recall number	`Z-1909-2016`
Product type	Medical device
Classification	Class III
Status	Terminated
Voluntary or mandated	Voluntary
Recalling firm	Affymetrix Inc, Warrensville Heights, OH, United States
Recall initiated	2016-04-14
Classified	2016-06-02
Reported by FDA	2016-06-08
Terminated	2016-08-17
Distributed	AR, CA, DC, MA, MI, MN, NC, NM, NY, PA, SC, TN, TX, WA, WV
Quantity	507 kits
Expiration dates	`2015-03-31`, `2015-12-31`, `2017-06-10`, `2017-10-14`, `2017-12-17`

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

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.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1909-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.