# FDA recall Z-1795-2026

> **Brahms GmbH** · Class II · device recall initiated 2026-03-12.

## 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

- **Recall number:** Z-1795-2026
- **Recalling firm:** Brahms GmbH
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2026-03-12
- **Report date:** 2026-04-15

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Hennigsdorf, Germany

## Primary source

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

## Citation

> AI Analytics. FDA recall Z-1795-2026. Retrieved 2026-07-20 from https://api.ai-analytics.org/recall/Z-1795-2026. Source: US FDA. Licensed CC0.

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