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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Vet
Medical Devices/Diagnostic Equipment

Cellavision DI-60 Morphology Analyzers Recalled for Result Misattribution

Agency Publication Date: November 21, 2025
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Summary

Cellavision AB has recalled 27 units of the Automated Digital Cell Morphology analyzer DI-60, used in veterinary diagnostic settings. The device's barcode reader may incorrectly read the barcode of a previously processed slide instead of the current one, which can lead to diagnostic results being assigned to the wrong patient. This recall involves the analyzer when used with Honeywell Vuquest or Jadk FM-5 barcode reader components.

Risk

If a barcode is misread, diagnostic information could be attributed to the wrong animal, potentially leading to incorrect medical decisions or delayed treatment. No specific injuries have been reported, but the error creates a risk of clinical misinterpretation.

What You Should Do

  1. Identify if your laboratory is using the Automated Digital Cell Morphology analyzer DI-60 (REF: BC-956-067) by checking the model and serial number on the device label.
  2. Check your device against the following serial numbers: 64669, 64377, 64378, 64379, 63811, 63816, 63821, 63812, 63813, 64134, 64135, 64136, 64639, 64650, 70007, 63737, 63746, 63752, 64252, 64280, 64521, 64522, 64590, 64598, 64010, 64011, or 64471.
  3. Stop using the recalled product. Contact the manufacturer or your distributor to arrange return, replacement, or correction.
  4. If you have animal health concerns regarding previous tests performed on this device, contact your veterinarian.
  5. Call the FDA Consumer Complaint hotline at 1-888-723-3332 if you have additional questions regarding this recall.

Your Remedy Options

๐Ÿ“‹Other Action
How to: Stop using the recalled product. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: Automated Digital Cell Morphology analyzer DI-60
Variants: Honeywell Vuquest barcode reader, Jadk FM-5 barcode reader
Model:
BC-956-067
Serial Numbers:
64669
64377
64378
64379
63811
63816
63821
63812
63813
64134
64135
64136
64639
64650
70007
63737
63746
63752
64252
64280
64521
64522
64590
64598
64010
64011
64471
UDI:
0735004097202

Recall #: V-0019-2026. IVD in conjunction with a Honeywell Vuquest or Jadk FM-5 barcode reader component.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 97900
Status: Active
Manufacturer: Cellavision AB
Sold By: Authorized distributors
Manufactured In: Sweden
Units Affected: 27 units
Distributed To: Florida
Agency Last Updated: December 8, 2025

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response