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Abbott/Vysis CLL Probe Recall

21 October 2021

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The GenQA CLL 2021 EQA identified a fault with Vysis 13q FISH probes, as a number of participants who used Abbott/Vysis CLL FISH probe failed to detect a known deletion of the 13q14.3 locus in an EQA patient sample.

 

We have since been made aware of an urgent field safety notice in which various batches of the Vysis probe have since been recalled, including Vysis LSI p53/ATM, and LSI D13S319/13q34/CEP 12 probes.

We urge users of Vysis CLL FISH probes to review the information available from the Medicines & Healthcare products Regulatory Agency, using the link below:

 

https://mhra-gov.filecamp.com/s/F1EWLjSjRDi5qxQ6/d

 

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