medical Class II Updated 2021-10-06

Abbott Molecular, Inc. recalls Vysis CLL FISH Probe Kit with the following components: Vysi

Recalled Product

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


Hazard / Issue

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

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: UDI: (01)00884999042780(10)XXXXX(17)211015(240)04N02-021; US Distribution: Part Number 04N02-021, Lot Numbers 517086, 518656; International Distribution: List/Part Numbers (Lot Number): 04N02-021 (517086, 518656), 04N02-022 (517516, 519303), 05J83-001/Part 32-191025 (517068).
View official government recall

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