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Affymetrix
Affymetrix, Inc. · Model 902111 · UDI-DI 00856826006166
2
510(k) clearances
2
Adverse events
2
Recalls
6
Facilities
Description
CytoScan™ Dx Post-PCR 15-30°C MOD E PW
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-03-20 | Agilent Technologies, Inc. | DNA Labeling Kit for use in sample labeling to be hybridized to oligonucleotide microarrays has a component, Human Reference DNA Female aliquot, affected by a mosaic aberration tha |
| 2016-04-14 | Affymetrix Inc | During a recent Ohio site inspection by the FDA it was discovered that warning statements needed to be included with the product shipment. |
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