Drug recall
REF: CC286297 or BS737162 Automated Digital Cell Morphology analyzer DI-60, IVD in conjunction with a…
FDA recall event 97835 · Class II · Cellavision AB
Key facts
| Event ID | 97835 |
|---|---|
| Recall numbers | Z-0542-2026 |
| Recalling firm | Cellavision AB |
| Product type | Devices |
| 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. |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| 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. |
| Initiation date | Oct 8, 2025 |
| Report date | Nov 26, 2025 |
| City | Lund |
| Country | Sweden |
| FEI number | 3003630693 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: