Device recall

Z-0542-2026: REF: CC286297 or BS737162 Automated Digital Cell Morphology analyzer DI-60, IVD…

FDA device recall · Class II · Cellavision AB

Key facts

Recall number (Z-number) Z-0542-2026
Recall event 97835
Product REF: CC286297 or BS737162 Automated Digital Cell Morphology analyzer DI-60, IVD in conjunction with a Honeywell Vuquest or Jadk FM-5 barcode reader component.
Product code JOY
Recalling firm Cellavision AB
Recall class Class II
Status Open, Classified
510(k) numbers K092868
FEI number 3003630693

At a glance

  • 1–9 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

Browse all FDA device recalls (products)