FDA Device recall Z-1795-2026
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 co…
- FDA Device
- Class II
- ongoing
- Published 2026-04-15
On 2026-04-15 the FDA classified a Class II recall of 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 co… by Brahms, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1795-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-03-12 |
| Published | 2026-04-15 |
| Last updated | 2026-09-13 11:58 UTC |
| Company | Brahms |
| Distribution | AL, CA, CT, DE, FL, GA, ID, IL, MN, NC, NY, OH, PA, TX, UT |
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
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.
Identifiers
| code_info | REF: 89986, UDI-DI: 04260157638976, Lots: 40102+R78, 40102+R79, 40102+R80. REF: 859075N, UDI-DI: 04260157632196, All Lots. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:58 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1795-2026%22
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