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Affymetrix

Affymetrix, Inc. · Model 902111 · UDI-DI 00856826006166

PFX
2
510(k) clearances
2
Adverse events
2
Recalls
6
Facilities

Description

CytoScan™ Dx Post-PCR 15-30°C MOD E PW

Recalls

DateFirmReason
2025-03-20Agilent 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
2016-04-14Affymetrix IncDuring 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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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.