Brahms GmbH recalls B¿R¿A¿H¿M¿S KRYPTOR compact REACT

Recalling company

Brahms GmbH

Product

B¿R¿A¿H¿M¿S KRYPTOR compact REACT, REF: 89986, used with B¿R¿A¿H¿M¿S PlGF Plus KRYPTOR, REF: 859075N, and run on the B¿R¿A¿H¿M¿S KRYPTOR compact PLUS analyzers. in vitro diagnostic test for Placental Growth Factor

Reason

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.

Classification

Class II – may cause temporary or medically reversible health consequences

Recall date

Mar 12, 2026

Reported

Apr 15, 2026

Distribution

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

Status

Ongoing

Quantity

5,524

Lot / codes

REF: 89986, UDI-DI: 04260157638976, Lots: 40102+R78, 40102+R79, 40102+R80. REF: 859075N, UDI-DI: 04260157632196, All Lots.

Company location

Hennigsdorf

Recall type

Voluntary: Firm initiated

Recall number

Z-1795-2026

Agency

U.S. Food and Drug Administration (FDA)

View official FDA notice ↗ Search recall number Z-1795-2026 in the FDA Enforcement Report. Also see FDA recall press releases.