Recall Z-2576-2021— Abbott Molecular, Inc.

Name: FDA recall Z-2576-2021
Creator: U.S. Food and Drug Administration
Published: 2021-08-04

Class II · Terminated

Class II FDA medical device recall by Abbott Molecular, Inc., initiated 2021-08-04, terminated 2023-05-31. FDA's recall record names no specific 510(k) clearance for this event. 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. Reason: Potential for Vysis CLL FISH Probe Kits not detecting 13q deletions in known positive patient samples..

Recalling firm: Abbott Molecular, Inc.
Classification: Class II
Status: Terminated
Initiated: 2021-08-04
Terminated: 2023-05-31
Firm location: Des Plaines, IL, United States

Product description

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

Reason for recall

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

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