FDA-Device2025-11-26Class IIPROCESSING DEFECT
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.
Hazard
Automated cell-locating device barcode reader may read the barcode of the previously processed slide resulting in a misattribution of diagnostic results.
Who it affects
All ages
Illnesses reported
None reported
Sold states
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.
Affected count
688 units
Manufactured in
Forskningsbyn Ideon, Scheelevagen 19a, Lund, Sweden
Products
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 notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0542-2026Don't want to check this manually?
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