Reported Apr 15, 2026 · Ongoing
B¿R¿A¿H¿M¿S KRYPTOR compact REACT, REF: 89986, used with B¿R¿A¿H¿M¿S PlGF Plus KRYPTOR, REF: 859075N, and run on the…
Brahms GmbH
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Brahms GmbH · Neuendorfstr. 25 · Hennigsdorf · N/A
Is this the product you have?
- B¿R¿A¿H¿M¿S KRYPTOR compact REACT
- REF89986, used with B¿R¿A¿H¿M¿S PlGF Plus KRYPTOR
- REF859075N, and run on the B¿R¿A¿H¿M¿S KRYPTOR compact PLUS analyzers. in vitro diagnostic test for Placental Growth Factor
- Lot codes and dates
- REF89986
- UDI-DI04260157638976
- Lots
40102+R7840102+R7940102+R80
- REF859075N
- UDI-DI04260157632196, All Lots
- Amount recalled
- 5,524
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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