Brahms GmbH — B.R.A.H.M.S PlGF Plus KRYPTOR, Catalog Number: 859075N. in vitro diagnostic test for Placental Growth Factor
⚠️ 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.
Is this relevant to me?
- Geography
- US, NC, TX, MN, UT, NY, FL, OH, IL, CT, CA, GA, DE, AT, AL, AU, BG, BR, CH, CZ, DK, ET, ES, FR, GB, GR, HK, HU, ID, IT, KW, KZ, LT, MK, ML, MX, NL, NO, PA, PL, PT, RO, SE, SI, TH, TU, TW, UA, ZA
- Source agency
- FDA
- Category
- Health
- Published
- March 12, 2026
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, ET, ES, FR, GB, GR, HK, HU, ID, IL, IT, KW, KZ, LT, MK, ML, MX, NL, NO, PA, PL, PT, RO, SE, SI, TH, TU, TW, UA, ZA
What's affected?
- Product
- B.R.A.H.M.S PlGF Plus KRYPTOR, Catalog Number: 859075N. in vitro diagnostic test for Placental Growth Factor
- Brand
- Brahms GmbH
- Lot code
- (Expiration):
Additional details
UDI: 04260157632196. Lot(Expiration): 59172(2026-11-23), 859075N(2026-11-23)
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 5,254.
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