DeviceClearance

Z-1795-2026

Class II · Ongoing

Recalling firm
Brahms GmbH
Classification
Class II
Status
Ongoing
Initiated
20260312
Firm location
Hennigsdorf, Germany

Product description

B.R.A.H.M.S PlGF Plus KRYPTOR, Catalog Number: 859075N. in vitro diagnostic test for Placental Growth Factor

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.