Severity
Low
LowClass IIITerminated
FDA Devices recall · Reported June 8, 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 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
During a recent Ohio site inspection by the FDA it was discovered that warning statements needed to be included with the product shipment.
Affymetrix Inc recalled CytoScan¿ Dx Assay. The CytoScan Dx Assay consists of five reagent modules, wash buffers … - a low-severity action.
CytoScan¿ Dx Assay. The CytoScan Dx Assay consists of five reagent modules, wash buffers … was recalled by Affymetrix Inc in June 8, 2016. Reason: During a recent Ohio site inspection by the FDA it was discovered that warning statements needed to be includ…. Check the official notice for the remedy. Verify recall #Z-1909-2016 with the FDA Devices before acting.
The recall
Affymetrix Inc issued this low-severity FDA Devices recall-During a recent Ohio site inspection by the FDA it was discovered that warning statements needed to be includ….
- Low
- severity level
- Class III
- classification
- June 8, 2016
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1909-2016 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1909-2016) was formally reported on June 8, 2016, with the manufacturer initiating the action on April 14, 2016. It is classified under Low severity (Class III), with a current status of Terminated. Affymetrix Inc is listed as the recalling firm, operating out of Warrensville Heights, OH. Federal records list the affected scope as 507 kits.
The documented reason for this recall is: During a recent Ohio site inspection by the FDA it was discovered that warning statements needed to be included with the product shipment. Distribution data in the federal record shows the product reached: Distributed in the US to the states of AR, CA, DC, MI, MA, MN, NC, NM, NY, PA, SC, TN, TX, WA and WV.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified low severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
507 kits
Related Recalls
6
3 from same agency
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Low (Class III) |
| Status | Terminated |
| Recall number | Z-1909-2016 |
| Date reported | June 8, 2016 |
| Date initiated | April 14, 2016 |
| Recalling firm | Affymetrix Inc |
| Firm location | Warrensville Heights, OH |
| Affected scope | 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. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-1909-2016) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Affymetrix Inc. Units affected: 507 kits.
Why was this product recalled? ▼
During a recent Ohio site inspection by the FDA it was discovered that warning statements needed to be included with the product shipment.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on June 8, 2016. Severity: Low. Recall number: Z-1909-2016.
Where was the recalled product distributed? ▼
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..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1909-2016) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported June 8, 2016. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.