Cellavision AB: Device Recall
Recall #Z-0542-2026 · 10/08/2025
Class II: Risk
Recall Details
- Recall Number
- Z-0542-2026
- Classification
- Class II
- Product Type
- Device
- Recalling Firm
- Cellavision AB
- Status
- Ongoing
- Date Initiated
- 10/08/2025
- Location
- Lund, Sweden
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 688 units
Reason for Recall
Automated cell-locating device barcode reader may read the barcode of the previously processed slide resulting in a misattribution of diagnostic results.
Product Description
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.
Distribution Pattern
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.
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.