Digital Cell Morphology Analyzer (Cellavision) – Barcode Reading Error (2025)
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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.
Brand
Cellavision AB Forskningsbyn Ideon Scheelevagen 19a Lund Sweden
Lot Codes / Batch Numbers
Not specified in FDA notice. Check official source for details.
Products Sold
UDI: 0735004097202/ Serial Numbers 63220-70093 or CN63220-CN70093 Serial Numbers 60001-63219 or CN60001-CN63219
Cellavision AB Forskningsbyn Ideon Scheelevagen 19a Lund Sweden is recalling REF: CC286297 or BS737162 Automated Digital Cell Morphology analyzer DI-60, IVD in conjunction with due to Automated cell-locating device barcode reader may read the barcode of the previously processed slide resulting in a misattribution of diagnostic resul. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Automated cell-locating device barcode reader may read the barcode of the previously processed slide resulting in a misattribution of diagnostic results.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026