Device recall

Z-2576-2021: Vysis CLL FISH Probe Kit with the following components: Vysis LSI p53…

FDA device recall · Class II · Abbott Molecular, Inc.

Key facts

Recall number (Z-number) Z-2576-2021
Recall event 88565
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
Product code OVQ
Recalling firm Abbott Molecular, Inc.
Recall class Class II
Status Terminated
Termination date May 31, 2023
FEI number 3005248192

At a glance

  • None Linked 510(k)s
  • 1–9 Products in the same recall event
  • 1–9 Recalled products with this product code

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About FDA device recalls (products)

Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.

Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database

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