Cellavision AB: REF: CC286297 or BS737162 Automated Digital Cell Morphology analyzer DI-60, IVD in conjunction with a Honeywell Vuquest or Jadk FM-5 barcod
Read the official notice at FDA (device) →
The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.
- Company / brand
- Cellavision AB
- 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.
- Reason / hazard
- Automated cell-locating device barcode reader may read the barcode of the previously processed slide resulting in a misattribution of diagnostic results.
- Classification
- Class II
- Status
- Ongoing
- Distribution / sold at
- US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, VT, WA, WI, WV, WY, PR.
- Recall initiated
- 2025-10-08
- Code info
- UDI: 0735004097202/ Serial Numbers 63220-70093 or CN63220-CN70093 Serial Numbers 60001-63219 or CN60001-CN63219
- Product quantity
- 688 units
- Voluntary mandated
- Voluntary: Firm initiated
- City
- Lund
- Country
- Sweden
- Event id
- 97835
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