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Vysis

ABBOTT MOLECULAR INC. · Model 04N02-020 · UDI-DI 00884999007772

OVQ Prescription
1
510(k) clearances
2
Adverse events
1
Recalls
1
Facilities

Description

Vysis CLL FISH Probe Kit

Recalls

DateFirmReason
2021-08-04Abbott Molecular, Inc.Potential for Vysis CLL FISH Probe Kits not detecting 13q deletions in known positive patient samples.

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Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

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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.