Reported Nov 26, 2025 · Ongoing

REF: CC286297 or BS737162 Automated Digital Cell Morphology analyzer DI-60, IVD in conjunction with a Honeywell Vuquest…

Cellavision AB

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Cellavision AB · Forskningsbyn Ideon · Lund · N/A

Is this the product you have?

  • REFCC286297 or BS737162 Automated Digital Cell Morphology analyzer DI-60, IVD in conjunction with a Honeywell Vuquest or Jadk FM-5 barcode reader component
Lot codes and dates
  • UDI0735004097202/ Serial Numbers 63220-70093 or CN63220-CN70093 Serial Numbers 60001-63219 or CN60001-CN63219
Amount recalled
688 units

Where it was sold

Why it was recalled

Automated cell-locating device barcode reader may read the barcode of the previously processed slide resulting in a misattribution of diagnostic results.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 5:45 PM UTC

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