Siemens Healthcare Diagnostics, Inc. is recalling 3,318 units of the IMMULITE 2000 Intact PTH assay (Test Code iPT) due to a risk of falsely low results for parathyroid hormone (PTH). The issue affects patient results at the low end of the testing range (50 pg/mL or lower) and has been observed in both serum and plasma samples used with IMMULITE 2000 and IMMULITE 2000 XPi systems. This recall involves 169 units in the United States and 3,149 units distributed internationally.
Falsely low parathyroid hormone results may lead to an incorrect diagnosis or medical mismanagement of conditions like hyperparathyroidism or bone and mineral disorders. Inaccurate laboratory data can cause clinicians to miss or delay necessary medical treatments.
Specifically used on IMMULITE 2000 and IMMULITE 2000 XPi systems.
Specifically used on IMMULITE 2000 and IMMULITE 2000 XPi systems.
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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