Brahms GmbH has recalled approximately 5,254 units of the B.R.A.H.M.S PlGF Plus KRYPTOR in vitro diagnostic test due to potential for inaccurate results. The company identified a defect where quality control values for the lowest level (QC Level 1) may fall out of range and go undetected if instructions are not strictly followed. This issue could lead to falsely elevated test ratios, potentially resulting in a patient being incorrectly classified as high-risk for preeclampsia. No injuries or incidents have been reported to date.
A falsely elevated sFlt-1/PlGF ratio may lead a healthcare provider to incorrectly believe a patient is at higher risk for progressing to preeclampsia with severe features. This could result in unnecessary medical interventions or intensified clinical monitoring for the patient.
Recall Number: Z-1795-2026; Quantity: 5,254 units affected.
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.
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Sources: FDA iRES · Raw API Response
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