Class 2 Device Recall Automated Digital Cell Morphology analyzer DI60

• Date Initiated by Firm: October 08, 2025
• Date Posted: November 18, 2025
• Recall Status: Open, Classified
• Recall Number: Z-0542-2026
• Recall Event ID: 97835
• 510(K)Number: K092868
• Product Classification: Device, automated cell-locating - Product Code JOY
• 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.
• Code Information: UDI: 0735004097202/ Serial Numbers 63220-70093 or CN63220-CN70093 Serial Numbers 60001-63219 or CN60001-CN63219
• FEI Number: 3003630693
• Recalling Firm/ Manufacturer: Cellavision AB; Forskningsbyn Ideon; Scheelevagen 19a; Lund Sweden
• For Additional Information Contact: Charlotte Oom; 46-2864400
• Manufacturer 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.
• FDA Determined 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 order matches the number of slides ordered. No order shall contain more slides than prescribed. b. Await contact from Sysmex service personnel, who will arrange installation of the updated CCU firmware. 3. You may continue to use the system(s) in accordance with its intended use, provided the above instructions are followed 4. Please ensure that this Correction Notification is circulated to all users of the device so that they are made aware of the potential issue. 5. Retain this letter until the firmware correction has been implemented. Ensure that the notice is kept in a visible and accessible location. 6. Fill in the customer response form and send via e-mail to whomever you received the Correction Notification from (or to any of the Sysmex America Inc. contacts found on page 1). The response must be sent as soon as possible, and no later than 30 days after you receive this Correction Notification.
• Quantity in Commerce: 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = JOY