FDA-Device2026-04-15Class IIPROCESSING DEFECT

Brahms B.R.A.H.M.S PlGF Plus KRYPTOR recalled for incorrect test results

FALSE CLAIMSAL CA CT DE FL GA ID IL MN NC NY OH PA TX UT Medical devices

What this means

Brahms GmbH is recalling certain lots of the B.R.A.H.M.S PlGF Plus KRYPTOR, a blood test used to assess preeclampsia risk during pregnancy. Quality control checks at the lowest level (QC Level 1) may show out-of-range values that could mask an underlying problem if not performed correctly. This could lead to falsely high test results that overestimate preeclampsia risk.

If you operate this device, verify that quality controls are performed exactly as written in the instructions
Review recent results for lots 59172 and 859075N (both expiring 2026-11-23)
Contact Brahms GmbH or your distributor for guidance on affected units
Report any unexpected quality control results to Brahms immediately

Get recalls like this in a free plain-English brief every Sunday.Get alerts ↓

The agency's original wording

Hazard

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.

Intended for

Adults

Illnesses reported

None reported

Sold states

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

Affected count

5,254

Manufactured in

Neuendorfstr. 25, Hennigsdorf, Germany

Products

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

Official notice

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

Want us to check the next one for you?

We read every CPSC, FDA, USDA, and NHTSA notice and email you a plain-English Sunday brief covering your household — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.