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U.S. Department of Health and Human Services

Class 3 Device Recall CytoScan Dx Assay

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  Class 3 Device Recall CytoScan Dx Assay see related information
Date Initiated by Firm April 14, 2016
Create Date June 03, 2016
Recall Status1 Terminated 3 on August 17, 2016
Recall Number Z-1909-2016
Recall Event ID 73979
510(K)Number K130313  
Product Classification System, microarray-based, genome-wide, postnatal chromosomal abnormality detection - Product Code PFX
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
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.
Recalling Firm/
Manufacturer		 Affymetrix Inc
26111 Miles Rd
Warrensville Heights OH 44128-5933
For Additional Information Contact
216-765-5000
Manufacturer 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.
FDA Determined
Cause 2		 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 in Commerce 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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