B.R.A.H.M.S PlGF Plus KRYPTOR, Catalog Number: 859075N. in vitro diagnostic tes...
Reason for Recall / Hazard
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.
Product Description & Identification
B.R.A.H.M.S PlGF Plus KRYPTOR, Catalog Number: 859075N. in vitro diagnostic test for Placental Growth Factor
Affected Products
B.R.A.H.M.S PlGF Plus KRYPTOR, Catalog Number: 859075N. in vitro diagnostic test for Placental Growth Factor
Additional Source Details
| Field | Value |
|---|---|
| City | Hennigsdorf |
| Event id | 98561 |
| Address 1 | Neuendorfstr. 25 |
| Code info | UDI: 04260157632196. Lot(Expiration): 59172(2026-11-23), 859075N(2026-11-23) |
| Postal code | N/A |
| Report date | 20260415 |
| Product type | Devices |
| Product quantity | 5,254 |
| 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. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260312 |
| Center classification date | 20260408 |
Overview
- Recalling FirmBrahms GmbH
- StatusOngoing
- Risk LevelClass II
- DistributionWorldwide 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, ET, ES, FR, GB, GR, HK, HU, ID, IL, IT, KW, KZ, LT, MK, ML, MX, NL, NO, PA, PL, PT, RO, SE, SI, TH, TU, TW, UA, ZA