FDA Medical Device Recalls (openFDA)
Affymetrix Inc: 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
- Recall number
- Z-1909-2016
- Recalling firm
- Affymetrix Inc
- 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 (-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
- Status
- Terminated
- Initiated
- 2016-04-14
- Posted
- not on file
- Terminated
- 2016-08-17
- Reason
- During a recent Ohio site inspection by the FDA it was discovered that warning statements needed to be included with the product shipment.
- Root cause
- Labeling design
- 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.
- Quantity
- 507 kits
- Distribution
- Distributed in the US to the states of AR, CA, DC, MI, MA, MN, NC, NM, NY, PA, SC, TN, TX, WA and WV.
- Lot, serial or model codes
- 4044094 exp 6/10/17; 4044095 exp 6/10/17 ;4044148 exp 10/14/17 ;4044149 exp 10/14/17 ;4044150 exp 12/17/17; 4044151 exp 12/17/17 ; 4044160* exp 3/31/15 and 4244477* exp 12/31/15. *Expiry of initial commercial lots was 12 -18 months.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- PFX
- Firm FEI
- 3008715426
- Firm city
- Warrensville Heights
- Firm state
- OH
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28