B.R.A.H.M.S PlGF Plus KRYPTOR
Brahms recalls PlGF Plus KRYPTOR test (REF 859075N) due to QC underestimation risk causing false preeclampsia risk classification.
Stop using the affected B.R.A.H.M.S PlGF Plus KRYPTOR test (REF 859075N) and contact Brahms GmbH for instructions on returning the product and obtaining a replacement.
Why it was recalled
Brahms GmbH is recalling the B.R.A.H.M.S PlGF Plus KRYPTOR in vitro diagnostic test (REF 859075N) because quality control values at the lowest level (QC Level 1) may be underestimated, leading to falsely elevated sFlt-1/PlGF ratio results. This could cause a higher-risk classification for progression to preeclampsia with severe features and potentially unnecessary intensified clinical monitoring.
Is mine affected?
Check the model, lot, or serial number on the device or its packaging. Yours is affected if it matches one below.
B.R.A.H.M.S PlGF Plus KRYPTOR, Catalog Number: 859075N. in vitro diagnostic test for Placental Growth Factor
- UDI-DI
- 04260157638976, 04260157632196
Where it was sold
Distributed in Alabama, California, Connecticut, Delaware, Florida, Georgia, Idaho, Illinois, Minnesota, North Carolina, New York, Ohio, Pennsylvania, Texas, and Utah.
Timeline
- Firm initiated recall
- Publicly announced
- Listed on Recall Canary
- Summary updated
Official source
Editorial summary by Recall Canary · summary updated 2026-07-28 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification