Abbott Molecular, Inc. 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 Recall

Check Your Product

According to the U.S. Food and Drug Administration (FDA)

Reason for Recall

As stated by FDA

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

Recommended Action

Per FDA guidance

On about 08/04/2021, Abbott Molecular notified consignees via FedEx with letter titled "Urgent Field Safety Notice Molecular Diagnostics at Abbott Product: Vysis CLL FISH Probe." The letter instructed customers to discontinue use of the affected lots, discard any remaining kits on hand, complete and return the customer reply form, and notify impacted customers if the affected lots have been further distributed. Additional instructions included to review the recall notification information with your Medical Director or physicians as appropriate and retain the communication for future reference. Review patient results generated with the impacted lots and determine if retesting is required taking patient medical history and previous treatment into consideration.