B.R.A.H.M.S PlGF Plus KRYPTOR In Vitro Diagnostic Test
B.R.A.H.M.S PlGF Plus KRYPTOR (Catalog 859075N) recalled for out-of-range quality control values that may cause falsely elevated preeclampsia risk results.
Contact B.R.A.H.M.S GmbH or your authorized distributor immediately to report any out-of-range QC Level 1 values and obtain troubleshooting guidance. Review all recent test results performed with affected units and consult with your laboratory director regarding potential impact on patient results.
Why it was recalled
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.
How to identify it
UPC 04260157632196
B.R.A.H.M.S PlGF Plus KRYPTOR, Catalog Number: 859075N. in vitro diagnostic test for Placental Growth Factor
Where it was sold
Distributed in US-AL, US-CA, US-CT, US-DE, US-FL, US-GA, US-ID, US-IL, US-MN, US-NC, US-NY, US-OH, US-PA, US-TX, US-UT.
Official source
Editorial summary by Recall Canary · last updated 2026-04-27 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification