FDA recall, , Moderate risk
Brahms B.R.A.H.M.S PlGF Plus KRYPTOR Diagnostic Test
The B.R.A.H.M.S PlGF Plus Kryptor test may show out-of-range quality control values, potentially leading to falsely elevated sFlt-1/PlGF ratio results.
Summary by Recall Canary from the FDA notice
What happened
Brahms GmbH is recalling the B.r.a.h.m.s PlGF Plus KRYPTOR, an in vitro diagnostic test for Placental Growth Factor, 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.
The recall began on March 12, 2026. Worldwide distribution includes US states such as NC, TX, MN, UT, NY, FL, OH, IL, CT, CA, GA, and other countries. The FDA added the recall to its Enforcement Report on April 8, 2026.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
Affected if its UDI-DI and lot code are listed under that product.
A UDI-DI is the device identifier printed with the barcode on the device label.
B.R.A.H.M.S PlGF Plus KRYPTOR, Catalog Number: 859075N. in vitro diagnostic test for Placental Growth Factor
- UDI-DI
- 04260157638976
- 04260157632196
- Lot code
- 40102
- R78
- R79
- R80
Recall details
- Company began the recall
- Sold in
Worldwide distribution. US states: North Carolina, Texas, Minnesota, Utah, New York, Florida, Ohio, Illinois, Connecticut, California, Georgia. Other countries: Delaware, AT, Alabama, AU, BG, BR, California, CH, CZ, DK, EC, ET, ES, FR, GB, GR, HK, HU, Idaho, Illinois, IT, KW, KZ, LT, MK, ML, MX, NL, NO, Pennsylvania, PL, PT, RO, RS, SE, SI, TH, TU, TW, UA, ZA
- Company
- Brahms GmbHHennigsdorf, Germany
- Hazard
- Device defect
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 98561
- Recall number
- Z-1795-2026
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
In FDA's weekly enforcement report
Listed on Recall Canary
Summary updated
