Z-0542-2026 Class II Ongoing
FDA device recall Z-0542-2026 was initiated by Cellavision AB on October 8, 2025 and is designated Class II. 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. The recall status is ongoing. Affected quantity: 688 units.
Recall Details
- Product Type
- Devices
- Report Date
- November 26, 2025
- Initiation Date
- October 8, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 688 units
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.
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.
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.
Code Information
UDI: 0735004097202/ Serial Numbers 63220-70093 or CN63220-CN70093 Serial Numbers 60001-63219 or CN60001-CN63219