Brahms recalls KRYPTOR compact REACT devices that may cause false high PlGF results, increasing preeclampsia risk. Affected units have specific model numbers and lot codes.
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.
Brahms is recalling KRYPTOR compact REACT devices used with PlGF Plus KRYPTOR that may give false high PlGF results. This could lead to misdiagnosis of severe preeclampsia in pregnant women. The recall affects specific model numbers and production lots.
The devices may produce false high PlGF results if quality control steps aren't followed. This could lead to misdiagnosis of severe preeclampsia, requiring more intensive monitoring.
Pregnant women using these devices for Placental Growth Factor testing are most at risk. The recall affects specific model numbers and production lots.
Check for model REF: 89986 with lots 40102+R78, 40102+R79, or 40102+R80. The device is used with PlGF Plus KRYPTOR REF: 859075N on Brahms KRYPTOR compact PLUS analyzers.
Look for lot numbers 40102+R78, 40102+R79, or 40102+R80 on the device packaging.
The device may produce false high PlGF results if quality control steps aren't followed, which could lead to misdiagnosis of severe preeclampsia.
Check for model REF: 89986 with lots 40102+R78, 40102+R79, or 40102+R80. The device is used with PlGF Plus KRYPTOR REF: 859075N on Brahms KRYPTOR compact PLUS analyzers.
The recall does not require stopping use; it only requires checking the lot number and following quality control steps.
We’ve drafted a message you can send Brahms to request your refund or repair — edit it as you like.
Subject: Recall Z-1795-2026 — Brahms Brahms Hello, I own a Brahms that is covered by recall Z-1795-2026 from Brahms. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
