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/ATMSpectrumGreen and LSI D13S319SpectrumOrange/ 13q34SpectrumAqua/CEP 12 SpectrumGreen Probes
- Lot codes and dates
3 of 3 products
Products covered by this recall Model / number Barcodes Product 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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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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