Cellavision AB 2025-11-26 Health serious FDA
Health · FDA · Recall #FDA-Z-0542-2026
REF: CC286297 or BS737162 Automated Digital Cell Morphology analyzer DI-60, IVD in… Recall
Issued November 26, 2025 · Cellavision AB
In November 2025, Cellavision AB recalled the REF: CC286297 or BS737162 Automated Digital Cell Morphology analyzer DI-60, IVD in…, a serious health recall reported by the FDA.
Compiled by Maya Ellison, RecallCheckr
What this means for you
Automated cell-locating device barcode reader may read the barcode of the previously processed slide resulting in a misattribution of diagnostic results.
What you should do
- 1 Stop using REF: CC286297 or BS737162 Automated Digital Cell Morphology analyzer DI-60, IVD in… right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact Cellavision AB to arrange your voluntary. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):
Recall details
- Brand
- Cellavision AB
- Category
- Health
- Recall date
- November 26, 2025
- Units affected
- Not reported
- Sold at
- 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, M
- Recall number
- FDA-Z-0542-2026
- Made in
- Sweden
- Issuing agency
- FDA
In context
- Cellavision AB has 1 recall in our database.
- We're tracking 3,576 Health recalls in our database.
- This is the 691st Health recall we've logged in 2025.