Z-1909-2016Class III

CytoScan Dx Assay. The CytoScan Dx Assay consists of five reagent modules, wash buffers (WS), a microarray...

Name: Z-1909-2016 CytoScan Dx Assay. The CytoScan Dx Assay consists of five reagent modules, wash buffers (WS), a microarray...
Creator: Affymetrix Inc
Published: 2016-04-14
License: https://open.fda.gov/license/

Affymetrix Inc / initiated 2016-04-14 / Terminated / root cause: labeling and UDI

FDA source

Affymetrix Inc began a recall of 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... on 2016-04-14. FDA classified it as Class III and gives the reason as "During a recent Ohio site inspection by the FDA it was discovered that warning statements needed to be included with the product shipment". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1909-2016
Classification: Class III
Status: Terminated
Initiated: 2016-04-14
Posted: 2016-06-03
Terminated: 2016-08-17
Recalling firm: Affymetrix Inc
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 (-20C) MOD T E W, CytoScan Dx Pre-PCR (2-8C) MOD F L H, CytoScan Dx Post-PCR (-20C) MOD S AH W PB, CytoScan Dx Post-PCR (2-8C) 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
Product code: PFX System, Microarray-Based, Genome-Wide, Postnatal Chromosomal Abnormality Detection
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.
Root cause tag: labeling and UDI
FDA root cause: Labeling design
Action: A letter dated April 14, 2016 was sent to customers. The letter stated the reason for the recall. It also informed customers that there is no impact on the performance of the assay. Customers were asked to either visit the IVD web portal (www.affymetrix.com/ivd) and review the warning statements; or, request a hard copy free of charge.
Quantity in commerce: 507 kits
Distribution: Distributed in the US to the states of AR, CA, DC, MI, MA, MN, NC, NM, NY, PA, SC, TN, TX, WA and WV.
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1909-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1909-2016	Class III	Terminated	Voluntary: Firm initiated	2016-06-08	2016-06-02

Product code PFX

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)