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FDA-Device2026-04-15Class IIPROCESSING DEFECT

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

Brahms
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Check your Brahms PlGF Plus KRYPTOR quality controls

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
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.

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

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