BRAHMS KRYPTOR compact REACT, REF: 89986, used with BRAHMS PlGF Plus KRYPTOR, REF: 859075N, and run on the BRAHMS KRYPTOR compact PLUS analyzers. in vitro diagnostic test for Placental Growth Factor

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.

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] On 3/12/2026, Follow-up notices were sent to customers who were informed the root cause had been identified, which identified reaction plate affected devices. Customers were asked to do the following: 1) Stop using and dispose affected reaction plates. 2) Complete and return the response form. 3) Same as point 3 above.