B¿R¿A¿H¿M¿S KRYPTOR compact REACT — Class II medical device recall Z-1795-2026
Ongoing recall by Brahms GmbH, reported 2026-04-15, distributed in CA, CT, FL, GA, ID, IL, MN, NC…. Customers have observed quality control values out of range at the lowest quality control level (QC Level 1) f
| Recall number | Z-1795-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Brahms GmbH, Hennigsdorf, Germany |
| Recall initiated | 2026-03-12 |
| Classified | 2026-04-08 |
| Reported by FDA | 2026-04-15 |
| Distributed | CA, CT, FL, GA, ID, IL, MN, NC, NY, OH, TX, UT |
| Quantity | 5,524 |
| Reason classes | potency |
| UPC / GTIN / UDI-DI | 04260157632196, 04260157638976 |
| Model numbers | 859075N, 89986 |
Product
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 B¿R¿A¿H¿M¿S KRYPTOR compact PLUS analyzers. in vitro diagnostic test for Placental Growth Factor
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1795-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.