Cellavision DI-60 Analyzer Recall: Barcode Misread Risk

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Recalling firmCellavision ABForskningsbyn Ideon, Scheelevagen 19a · Lund, N/A

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✎ GovInfoNow plain-language explainer

What happened, in plain English

Cellav: Cellavision AB is recalling DI-60 automated cell morphology analyzers that use Honeywell Vuquest barcode readers. The device may misread barcodes from previously processed slides, leading to incorrect diagnostic results. This could affect lab results and patient care.

Why it’s dangerous

The barcode reader may misread the barcode of a previously processed slide, causing the system to attribute diagnostic results to the wrong sample. This could lead to incorrect lab results being reported for patient care.

Who’s affected

Pathology labs using Cellavision DI-60 analyzers with Honeywell Vuquest barcode readers are most at risk. Patients receiving lab tests from these devices may be affected if results are misattributed.

How to tell if you have this one

Check for the model DI-60 with Honeywell Vuquest or Jadk FM-5 barcode reader. The serial numbers range from 60001-63219 or CN60001-CN63219, or 63220-70093 or CN63220-CN70093.

Brand
Cellavision
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Device Serial Numbers
Review the serial numbers on your device to see if they fall within the ranges 60001-63219 or 63220-70093.

✎ GovInfoNow

Questions people ask

What could happen if the barcode is misread?

The device may misattribute diagnostic results to the wrong sample, leading to incorrect lab results.

How can I tell if my device is affected?

Check the serial numbers: 60001-63219 or CN60001-CN63219, or 63220-70093 or CN63220-CN70093.

Is there a fix for this issue?

The recall does not specify a fix; affected devices must be checked for the serial number ranges.

Take action

Contact Cellavision

We’ve drafted a message you can send Cellavision to request your refund or repair — edit it as you like.

✉️ Open in email

Subject: Recall Z-0542-2026 — Cellavision Cellavision

Hello,

I own a Cellavision that is covered by recall Z-0542-2026 from Cellavision.

I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this?

Thank you.

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-0542-2026 (October 8, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0542-2026 to see it in context.
Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.

Cellavision AB recalls REF: CC286297 or BS737162 Automated Digital Cell Morphology analyzer DI-60, IVD in conjunction with a Honeywell Vuquest

Lower-risk recall