Device recall

Z-0741-2022: Del(5q) Deletion FISH Probe Kit: In-Vitro Diagnostic to detect deletions in…

FDA device recall · Class II · Cytocell Ltd.

Key facts

Recall number (Z-number) Z-0741-2022
Recall event 89602
Product Del(5q) Deletion FISH Probe Kit: In-Vitro Diagnostic to detect deletions in chromosome location from patients with AML or MDS Catalog Number: USA-LPH024
Product code QDI
Recalling firm Cytocell Ltd.
Recall class Class II
Status Terminated
Termination date Nov 8, 2024
FEI number 3002646096

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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