Reported Jun 8, 2016 · Terminated
CytoScan¿ Dx Assay. The CytoScan Dx Assay consists of five reagent modules, wash buffers (WS), a microarray kit, and…
Affymetrix Inc.
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Affymetrix Inc · 26111 Miles Rd · Warrensville Heights, OH · 44128-5933
Is this the product you have?
- 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 softwareMOD 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
- Lot codes and dates
- 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.
- Amount recalled
- 507 kits
Where it was sold
Why it was recalled
During a recent Ohio site inspection by the FDA it was discovered that warning statements needed to be included with the product shipment.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new Affymetrix Inc. recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.