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.
Reported: November 26, 2025 Initiated: October 8, 2025 #Z-0542-2026
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.
Details
- Recalling Firm
- Cellavision AB
- Units Affected
- 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.
- Location
- Lund
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Cellavision AB. Units affected: 688 units.
Why was this product recalled? ▼
Automated cell-locating device barcode reader may read the barcode of the previously processed slide resulting in a misattribution of diagnostic results.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 26, 2025. Severity: Moderate. Recall number: Z-0542-2026.
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