Recall Z-0542-2026 ยท JOY Device, Automated Cell-Locating
Cellavision AB
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.
| Date | Nov 18, 2025 (initiated Oct 8, 2025) |
| Status | Open, Classified |
| Reason | Automated cell-locating device barcode reader may read the barcode of the previously processed slide resulting in a misattribution of diagnostic results. |
| Root cause | Software design |
| Action | On October 10, 2025, CellaVision issued a "Urgent Medical Device Correction" Notification to affected consignees via US Mail and Email. Accompanying the notice was Technical Note TN148. CellaVision asked consignees to take the following action: 1. Identify whether any of your DI-60 analyzer(s) are affected by verifying the serial number(s) against the list of affected units provided in Table 1. 2. If your unit(s) are affected, please implement the following interim measure to mitigate the risk of sample misattribution: a. Before signing each order, confirm that the number of slides in the or |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K092868 | CELLAVISION DM1200 AUTOMATED HEMATOLOGY ANALYZER, MODEL XU-10127 CellaVision AB, Nov 20, 2009 |