CytoScan¿ Dx Assay. The CytoScan Dx Assay consists of recall
CytoScan¿ Dx Assay. The CytoScan Dx Assay consists of five reagent modules, wash buffers (WS), a microarray kit, and analysis software. The CytoScan…
Why was CytoScan¿ Dx Assay. The CytoScan Dx Assay consists of recalled?
During a recent Ohio site inspection by the FDA it was discovered that warning statements needed to be included with the product shipment.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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.
- Product
- CytoScan¿ Dx Assay. The CytoScan Dx Assay consists of five reagent modules, wash buffers (WS), a microarray kit, and analysis software. The CytoScan…
- Recalling firm
- Affymetrix Inc
- 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.
- Recall date
- June 8, 2016
- Classification
- Class III
- Status
- Terminated
- Agency
- FDA (device)