Z-1795-2026 Class II Ongoing
FDA device recall Z-1795-2026 was initiated by Brahms GmbH on March 12, 2026 and is designated Class II. 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… The recall status is ongoing. Affected quantity: 5,524.
Recall Details
- Product Type
- Devices
- Report Date
- April 15, 2026
- Initiation Date
- March 12, 2026
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 5,524
Product Description
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.
Distribution Pattern
Worldwide distribution. US states: NC, TX, MN, UT, NY, FL, OH, IL, CT, CA, GA. Other countries: DE, AT, AL, AU, BG, BR, CA, CH, CZ, DK, EC, ET, ES, FR, GB, GR, HK, HU, ID, IL, IT, KW, KZ, LT, MK, ML, MX, NL, NO, PA, PL, PT, RO, RS, SE, SI, TH, TU, TW, UA, ZA
Code Information
REF: 89986, UDI-DI: 04260157638976, Lots: 40102+R78, 40102+R79, 40102+R80. REF: 859075N, UDI-DI: 04260157632196, All Lots.