The Recall Desk
Agency classClass IIIOur severity:LowFDA (Devices)·Z-1909-2016·Announced 2016-06-08

Affymetrix Recalls CytoScan Dx Assay Kits Due to Missing Warning Statements

Affymetrix is recalling 507 CytoScan Dx Assay kits because FDA inspectors found that required warning statements were missing from product shipments.

The agency’s classification

FDA (Devices): Class III

Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 1/5 (Low).

Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.

Our severity reasoning: The agency classified this as a Class III recall, which the rubric defines as typically resulting in a score of 1 or 2 because it is unlikely to cause adverse health consequences. The issue is a documentation/packaging error (missing warning statements) rather than a direct physical hazard.

Plain-English summary

Affymetrix Inc is recalling 507 kits of the CytoScan Dx Assay. The recall was initiated after a recent FDA site inspection in Ohio revealed that warning statements needed to be included with the product shipment but were missing.

The affected product consists of five reagent modules, wash buffers, a microarray kit, and analysis software. The kits were distributed in the US to the states of AR, CA, DC, MI, MA, MN, NC, NM, NY, PA, SC, TN, TX, WA, and WV.

The agency has classified this recall as Class III, indicating that use of or exposure to the violative product is not likely to cause adverse health consequences. Users should stop using the affected kits and contact Affymetrix for instructions on return or replacement.

The recalled product

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…
Manufacturer
Affymetrix Inc
Category
Medical Device — In Vitro Diagnostics
Hazard
Affected units
507

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (6)

  • 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

Distribution

Distributed in 15 states:

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