Recall Z-1909-2016 ยท PFX System, Microarray-Based, Genome-Wide, Postnatal Chromosomal Abnormality Detection
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-
| Date | Apr 14, 2016 |
| Status | Terminated |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.