Approximately 688 Cellavision DI-60 Automated Digital Cell Morphology analyzers are being recalled because the barcode reader component may incorrectly read the barcode of a previously processed slide. This defect can lead to lab results being assigned to the wrong patient, potentially causing diagnostic errors. The affected units were manufactured in Sweden and are used in clinical laboratories with Honeywell Vuquest or Jadk FM-5 barcode readers.
If a barcode is misread, diagnostic results may be attributed to the wrong patient. This could lead to incorrect medical diagnoses or improper treatment decisions based on inaccurate laboratory data.
IVD device; Recall #: Z-0542-2026
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.
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 · Raw API Response
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