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Updated 2026-04-15

Brahms GmbH recalls B.R.A.H.M.S PlGF Plus KRYPTOR, Catalog Number: 859075N. in

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Recalled Product

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

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Hazard / Issue

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.

Issued by

FDA

Affected States: NC, TX, MN, UT, NY, FL, OH, IL, CT, CA, GA, DE, AL, ID, PA
Lot/Code Info: UDI: 04260157632196. Lot(Expiration): 59172(2026-11-23), 859075N(2026-11-23)

✅ What Should You Do?

  1. 1Contact your healthcare provider immediately to discuss this recall.
  2. 2Stop using the device if it is safe to do so, and contact your provider.
  3. 3Follow the manufacturer's remedy instructions provided in the recall notice.
  4. 4Report device problems to FDA MedWatch or call 1-800-FDA-1088.

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