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U.S. Department of Health and Human Services

Class 2 Device Recall BRAHMS PlGF Plus KRYPTOR

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 Class 2 Device Recall BRAHMS PlGF Plus KRYPTORsee related information
Date Initiated by FirmMarch 12, 2026
Date PostedApril 08, 2026
Recall Status1 Open3, Classified
Recall NumberZ-1795-2026
Recall Event ID 98561
Product Classification Prognostic test for development or progression of preeclampsia - Product Code QWH
ProductB.R.A.H.M.S PlGF Plus KRYPTOR, Catalog Number: 859075N. in vitro diagnostic test for Placental Growth Factor
Code Information UDI: 04260157632196. Lot(Expiration): 59172(2026-11-23), 859075N(2026-11-23)
FEI Number 3003561301
Recalling Firm/
Manufacturer		 Brahms GmbH
Neuendorfstr. 25
Hennigsdorf Germany
For Additional Information Contact
410 972 2452
Manufacturer 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.
FDA Determined
Cause 2		Under Investigation by firm
ActionOn 2/27/2026, correction notices were sent to customers informing them: 1. Continue to perform Quality Control testing in accordance with the current Instructions for Use prior to reporting patient results. 2. If Quality Control results fall outside plus-minus 20% of target values follow the troubleshooting procedures described in the User Manual. 3. Forward this letter to those who need to be aware within your organization or to any organization to whom the potentially affected devices have been transferred. Keep this notification on file. For further questions, please contact the firm's customer service on 1-800-232-3342 or e-mail to: USFMTMGC-TechnicalService@thermo.com
Quantity in Commerce5,254
DistributionWorldwide 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
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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