# FDA recall Z-0542-2026

> **Cellavision AB** · Class II · device recall initiated 2025-10-08.

## 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.

## 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

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.

## Key facts

- **Recall number:** Z-0542-2026
- **Recalling firm:** Cellavision AB
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-10-08
- **Report date:** 2025-11-26

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Lund, Sweden

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0542-2026

## Citation

> AI Analytics. FDA recall Z-0542-2026. Retrieved 2026-09-21 from https://api.ai-analytics.org/recall/Z-0542-2026. Source: US FDA. Licensed CC0.

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