Reported Oct 6, 2021 · Terminated

Vysis CLL FISH Probe Kit with the following components: Vysis LSI p53 SpectrumOrange/ATM, SpectrumGreen and LSI…

Abbott Molecular, Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Abbott Molecular, Inc. · 1300 E Touhy Ave · Des Plaines, IL · 60018-3315

Is this the product you have?

  • Vysis CLL FISH
  • Probe Kit with the following components
    • Vysis LSI p53 SpectrumOrange/ATM
    • SpectrumGreen and LSI D13S319
    • SpectrumOrange/ 13q34
    • SpectrumAqua/CEP 12 SpectrumGreen Probes
Lot codes and dates

3 of 3 products

Products covered by this recall
Model / numberBarcodesProduct as published
00884999042780(01)00884999042780(10)XXXXX(17)211015(240)04N02-021
04N02-021US Distribution: , Lot Numbers 517086, 518656
32-191025International Distribution: List/Part Numbers (Lot Number): 04N02-021 (517086, 518656), 04N02-022 (517516, 519303), 05J83-001/ (517068).
Amount recalled
186 units

Where it was sold

Why it was recalled

Potential for Vysis CLL FISH Probe Kits not detecting 13q deletions in known positive patient samples.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated May 31, 2023 · Data as of Sep 19, 5:42 PM UTC

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