- Recalling firm
- Brahms GmbH
- Reason for recall
- 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.
- Affected products (lot / model / serial)
- REF: 89986, UDI-DI: 04260157638976, Lots: 40102+R78, 40102+R79, 40102+R80. REF: 859075N, UDI-DI: 04260157632196, All Lots.
- Units affected
- 5,524
- Distribution pattern
- Worldwide distribution. US states: NC, TX, MN, UT, NY, FL, OH, IL, CT, CA, GA. Other countries: DE, AT, AL, AU, BG, BR, CA, CH, CZ, DK, EC, ET, ES, FR, GB, GR, HK, HU, ID, IL, IT, KW, KZ, LT, MK, ML, MX, NL, NO, PA, PL, PT, RO, RS, SE, SI, TH, TU, TW, UA, ZA
- Firm location
- Hennigsdorf, Germany
- Recall type
- Voluntary: Firm initiated
- Product type
- Devices
- Status
- Ongoing
- Recall number
- Z-1795-2026
- Recall initiated
- March 12, 2026
- FDA classification date
- April 8, 2026
- FDA report date
- April 15, 2026
- FDA event ID
- 98561
- Last updated on HTM Vibe
- July 28, 2026