Z-1909-2016 Class III Terminated
FDA device recall Z-1909-2016 was initiated by Affymetrix Inc on April 14, 2016 and is designated Class III. Reason for recall: During a recent Ohio site inspection by the FDA it was discovered that warning statements needed to be included with the product shipment. The recall status is terminated (terminated August 17, 2016). Affected quantity: 507 kits.
Recall Details
- Product Type
- Devices
- Report Date
- June 8, 2016
- Initiation Date
- April 14, 2016
- Termination Date
- August 17, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 507 kits
Product Description
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 for Recall
During a recent Ohio site inspection by the FDA it was discovered that warning statements needed to be included with the product shipment.
Distribution Pattern
Distributed in the US to the states of AR, CA, DC, MI, MA, MN, NC, NM, NY, PA, SC, TN, TX, WA and WV.
Code Information
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.