Beckman Coulter, Inc. is recalling approximately 725,568 units of Access Substrate, used with Access Immunoassay medical diagnostic systems, because various bottles were released from manufacturing without labels. A missing label on these bottles can lead to a lack of identification in laboratory settings, potentially causing delays in reporting patient test results. While the defect is easily recognized by lab personnel and labs typically have backup systems to prevent clinical impact, the product is being recalled to ensure proper labeling and regulatory compliance.
The lack of labels on diagnostic reagent bottles may cause confusion or processing delays in clinical laboratories, which could delay the delivery of patient medical results. Although no erroneous results are expected, any delay in diagnostic reporting can potentially impact the timing of clinical management for patients.
Manufacturer instructions for field action on unlabeled reagent bottles.
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.
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Sources: FDA iRES · Raw API Response
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