Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1909-2016 — 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

U.S. FDA — Device Enforcement · United States · 2016-04-14 · Class III

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1909-2016
Date of alert: 2016-04-14
Country / jurisdiction: United States
Risk level: Class III
Risk type: recall
Brand: Affymetrix Inc
Product category: device
Product type: Devices

Reported risk: During a recent Ohio site inspection by the FDA it was discovered that warning statements needed to be included with the product shipment.

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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