REF: CC286297 or BS737162 Automated Digital Cell Morphology analyzer DI-60, IVD in conjunction with a Honeywell Vuquest
FDA device recall Z-0542-2026 · posted 2025-11-18 · Open, Classified
Recall details
- Recalling firm
- Cellavision AB
- 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.
- Action taken
- 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.
- Root cause
- Software design
- Status
- Open, Classified
- Product code
- JOY
- Quantity 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
- Date initiated
- 2025-10-08
- Date posted
- 2025-11-18
- Location
- Lund, Sweden
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| CELLAVISION DM1200 AUTOMATED HEMATOLOGY ANALYZER, MODEL XU-10127 (K092868) | CellaVision AB | 2009-11-20 |