[Recalled] 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,
Authorities recorded a safety problem with this product. The details below come directly from the government recall notice.
Recall details
| 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 |
|---|---|
| Brand / manufacturer | Affymetrix Inc |
| Category | device |
| Issuing authority | FDA_DEVICE |
| Reference | Z-1909-2016 |
| Country of notice | United States |
| Risk level | Class III |
| Hazard type | recall |
| Notice date | 14 April 2016 |
Why it was recalled
According to the FDA_DEVICE notice, the identified hazard is: During a recent Ohio site inspection by the FDA it was discovered that warning statements needed to be included with the product shipment.
This Class III recall concerns device products distributed in United States and was recorded by FDA_DEVICE. Recalls in this category are published so that owners, retailers, and importers can identify affected units and act quickly.
What to do if you own this product
Check whether your unit is affected and follow the authority's guidance before further use.
Read the full official notice →
This page indexes a public government recall notice for reference. We do not sell or verify this product; always confirm the current status on the authority's official site.