This recall involves 15 units of the Inpeco FlexLab (FLX) Aliquoter Module (mALX), versions FLX-217-10 and FLX-217-40. The module may produce secondary sample tubes that are either missing labels or have labels that do not match the original sample, which can lead to erroneous results. This error occurs if operators do not properly empty the printer tubes buffer after opening the printer head for maintenance or error recovery. Laboratory personnel should contact the manufacturer or their distributor to arrange for necessary corrections to ensure patient samples are handled safely.
Mismatched or missing labels on sample tubes can lead to delayed medical results or erroneous patient data, which may result in incorrect medical treatment decisions or delayed diagnoses.
Recall #: Z-0595-2026; Quantity: 1 unit (OUS only).
Recall #: Z-0596-2026; Quantity: 14 units (1 US, 13 OUS).
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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