Brahms GmbH recalled 5,254 units of the PlGF Plus KRYPTOR in vitro diagnostic test worldwide after reports of QC values out of range at QC Level 1. The issue may cause falsely elevated sFlt-1/PlGF ratios and higher risk classifications for preeclampsia progression. Stop using the device immediately and follow manufacturer recall instructions.
Customers have observed quality control values out of range at the lowest quality control level (QC Level 1) for the PIGF assay which require troubleshooting steps to resolve. If Quality Controls are not performed according to the Instructions for Use, the underestimation of QC1 may go undetected and could contribute to falsely elevated sFlt-1/PlGF ratio results. A falsely elevated sFlt-1/PlGF ratio may result in a higher-risk classification for progression to preeclampsia with severe features potentially leading to intensified clinical monitoring.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Brahms GmbH or your healthcare provider for instructions
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PlGF Plus KRYPTOR is an in vitro diagnostic test measuring placental growth factor for preeclampsia risk assessment. Used in clinical settings to guide patient monitoring.
Out-of-range QC values at the lowest QC level may lead to underestimation during QC checks, resulting in falsely high sFlt-1/PlGF ratios and misclassification of preeclampsia risk.
This recall is not part of a broader industry pattern.
Potential for incorrect patient risk stratification and inappropriate clinical decisions; immediate action required.
Look up the FDA recall page Z-1795-2026 for details; contact Brahms GmbH for instructions
Refunds or replacements coordinated by Brahms GmbH; follow official guidance
Keep recall notice, QC logs, testing results, supplier communications
Brand: Brahms GmbH. Product: PlGF Plus KRYPTOR. Catalog Number: 859075N. UDI: 04260157632196. Lot/Expiration: 59172(2026-11-23); 859075N(2026-11-23). Distribution: Worldwide. Recall Date: 2026-03-12. Status: ACTIVE.
No explicit injury or patient harm incidents are described in the provided data.
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