FDA Device recall Z-1909-2016
CytoScan¿ Dx Assay
- FDA Device
- Class III
- terminated
- Published 2016-06-08
On 2016-06-08 the FDA classified a Class III recall of CytoScan¿ Dx Assay by Affymetrix, citing during a recent Ohio site inspection by the FDA it was discovered that warning statements needed to be included with the product shipment.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1909-2016 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2016-04-14 |
| Published | 2016-06-08 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Affymetrix |
| Distribution | AR, CA, DC, MA, MI, MN, NC, NM, NY, PA, SC, TN, TX, WA, WV |
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
During a recent Ohio site inspection by the FDA it was discovered that warning statements needed to be included with the product shipment.
Identifiers
| code_info | 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…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. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1909-2016%22
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