Recall record at a glance
| Official record | Z-1909-2016 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class III |
| FDA record status | Terminated |
| Recalling firm | Affymetrix Inc. |
| Report date | Jun 8, 2016 |
| Recall initiation date | Apr 14, 2016 |
| Quantity | 507 kits |
| Location | Warrensville Heights, OH, United States |
Official 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
Why the product 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.
Distribution information
Distributed in the US to the states of AR, CA, DC, MI, MA, MN, NC, NM, NY, PA, SC, TN, TX, WA and WV.
How to read the classification
FDA Class III generally covers situations in which use of or exposure to the product is not likely to cause adverse health consequences. The classification displayed here is taken from the FDA enforcement record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: Letter.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
Recall Lookup USA preserves the most complete source information successfully retrieved. We do not create missing facts or infer affected lots or VINs. The official record may still change, so use the identifier above when verifying current instructions.
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