Class II — Cellavision AB
| Recalling firm | CellaVision AB |
|---|---|
| Registered facility | CELLAVISION AB (the firm's only registered facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | Automated cell-locating device barcode reader may read the barcode of the previously processed slide resulting in a misattribution of diagnostic results. |
| 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. |
| Quantity | 688 units |
| Distribution | 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. |
| Initiated | 2025-10-08 |
| Classified | 2025-11-18 |
| Recall number | Z-0542-2026 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Cellavision AB (Z-0542-2026).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/97835/
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