Beckman Coulter is recalling 2,805 units of Access TSH (3rd IS) reagent packs used with the Access Immunoassay Systems. These specific reagent lots may produce incorrectly low thyroid-stimulating hormone (TSH) results for patients. This assay is a diagnostic tool used to identify thyroid or pituitary disorders, and inaccurate results could lead to improper patient management. Consumers and healthcare providers should contact the manufacturer or their healthcare provider for further instructions.
The reagent packs may provide erroneously low TSH measurements, which can lead to a misdiagnosis of thyroid or pituitary conditions or the improper monitoring of existing thyroid treatments.
Manufacturer Notification
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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