FDAOctober 8, 2025device
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.
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Automated cell-locating device barcode reader may read the barcode of the previously processed slide resulting in a misattribution of diagnostic results.
What to do
FDA enforcement status: Ongoing
Brands named
cellavision abcellavision
UPCs
0735004097202
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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