Recall Z-1909-2016— Affymetrix Inc
Class III · Terminated
Class III FDA medical device recall by Affymetrix Inc, initiated 2016-04-14, terminated 2016-08-17. FDA's recall record names no specific 510(k) clearance for this event. 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. Reason: During a recent Ohio site inspection by the FDA it was discovered that warning statements needed to be included with the product shipment..
- Recalling firm
- Affymetrix Inc
- Classification
- Class III
- Status
- Terminated
- Initiated
- 2016-04-14
- Terminated
- 2016-08-17
- Firm location
- Warrensville Heights, OH, United States
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.
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