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REF: CC286297 or BS737162 recallZ-0542-2026 · Cellavision AB · initiated Oct 8, 2025

Class II Open, Classified All recalls posted in November 2025

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Cellavision AB or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

Automated cell-locating device barcode reader may read the barcode of the previously processed slide resulting in a misattribution of diagnostic results.

FDA root cause category: Software design

What the company is doing

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.

Recall details

Recall number
Z-0542-2026
Recall class
Class II
Status
Open, Classified
Initiated by the company
Oct 8, 2025
Posted by the FDA
Nov 18, 2025
Recalling firm
Cellavision AB
Quantity
688 units
Product code
JOY
FDA submissions
K092868
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.

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.

Code information (models, lots, serial numbers)

UDI: 0735004097202/ Serial Numbers 63220-70093 or CN63220-CN70093 Serial Numbers 60001-63219 or CN60001-CN63219

Other devices under the same FDA submission

1 device cleared under K092868 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Sources and updates

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