FDA recall Z-1795-2026

Product

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.

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, 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

Key facts

Status

Ongoing

Initiation date

2026-03-12

Report date

2026-04-15

Voluntary/Mandated

Voluntary: Firm initiated

Location

Hennigsdorf, Germany

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1795-2026