B.R.A.H.M.S PlGF Plus KRYPTOR, Catalog Number: 859075N. in vitro diagnostic test for Placental Growth Factor
B.R.A.H.M.S PlGF Plus KRYPTOR, Catalog Number: 859075N. in vitro diagnostic test for Placental Growth Factor was recalled because 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.. If you have this product, stop using it until you verify your lot or model details.
By RecallRadar Editorial Team
Sourced from FDA. Last verified April 20, 2026.
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Check if you qualifyKey facts
- Date announced
- April 15, 2026
- Source agency
- FDA
This recall involves safety concerns. Take action promptly.
✨ Plain-English Summary
B.R.A.H.M.S PlGF Plus KRYPTOR, Catalog Number: 859075N. in vitro diagnostic test for Placental Growth Factor was recalled because 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.. If you have this product, stop using it until you verify your lot or model details.
Is This Recall Still Active?
Status: Yes - Active
This recall is currently active. If your device matches the affected models, follow the official instructions as soon as possible.
What's Being Recalled
Quoted source excerpt from the official notice.
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.
Quick Info
Key facts from the official notice, kept in the article flow for easy cross-checking.
- Brand
- Brahms gmbh
- Category
- medical
- Source agency
- FDA
- Announced
- April 15, 2026
- Country
- US
- Status
- Active
Who's Affected
Specific models and identifiers listed in the source notice:
Model #1
UDI: 04260157632196. Lot(Expiration): 59172(2026-11-23), 859075N(2026-11-23)
| # | Model |
|---|---|
| 1 | UDI: 04260157632196. Lot(Expiration): 59172(2026-11-23), 859075N(2026-11-23) |
Technical model codes are manufacturer identifiers. Match both the product name and model code from your device settings, label, or packaging.
What You Should Do
Follow the remedy path from the official notice using the exact model and serial details above.
- 1Stop using the affected product until you verify whether your item is impacted.
- 2Check the official recall notice and match your model, lot, or serial details.
- 3Follow the official instructions for repair, replacement, refund, or disposal.
Source & Verification
This page summarizes the official notice and keeps key facts easy to verify.
- Official source
- FDA
- Announced by source
- April 15, 2026
- Last reviewed by RecallRadar
- April 20, 2026
Frequently Asked Questions
Am I affected by this recall?
Check the affected models section on this page. The official notice currently lists UDI: 04260157632196. Lot(Expiration): 59172(2026-11-23), 859075N(2026-11-23).
What is the remedy for this recall?
Follow the official instructions for repair, replacement, refund, or disposal on the brahms gmbh recall page.
Where can I verify recall details?
Use the official source link in this page to confirm dates, eligibility, and next steps: https://api.fda.gov/device/enforcement.json?search=recall_number:Z-1795-2026&limit=1
Keep browsing with these internal hubs: brahms gmbh recall hub and Medical recall hub.
Official Resources
Use these primary sources for final eligibility and claim instructions.
View official notice from FDASee an inaccuracy?
Help us improve the accuracy of this recall information.
On this page
Free checker
Check if you qualify
See whether your device may qualify for a free repair or replacement program before you spend money.
Check if you qualifyKey facts
- Date announced
- April 15, 2026
- Source agency
- FDA
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