Z-1795-2026Class II

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

Name: Z-1795-2026 B.R.A.H.M.S PlGF Plus KRYPTOR, Catalog Number: 859075N. in vitro diagnostic test for Placental Growth Factor
Creator: Brahms GmbH
Published: 2026-03-12
License: https://open.fda.gov/license/

B.R.A.H.M.S GmbH / initiated 2026-03-12 / Open, Classified / root cause: labeling and UDI

FDA source

Brahms GmbH began a recall of B.R.A.H.M.S PlGF Plus KRYPTOR, Catalog Number: 859075N. in vitro diagnostic test for Placental Growth Factor on 2026-03-12. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1795-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-03-12
Posted: 2026-04-08
Recalling firm: B.R.A.H.M.S GmbH
Product: B.R.A.H.M.S PlGF Plus KRYPTOR, Catalog Number: 859075N. in vitro diagnostic test for Placental Growth Factor
Product code: QWH Prognostic Test For Development Or Progression Of Preeclampsia
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.
Root cause tag: labeling and UDI
FDA root cause: Under Investigation by firm
Action: On 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: [email protected]
Quantity in commerce: 5,254
Distribution: 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
Product codes and lots: UDI: 04260157632196. Lot(Expiration): 59172(2026-11-23), 859075N(2026-11-23)

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1795-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1795-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-04-15	2026-04-08

Product code QWH

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)