fda_recall · device_recall · high

Brahms GmbH — Class II recall: B.R.A.H.M.S PlGF Plus KRYPTOR, Catalog Number: 859075N. in vitro diagnostic tes…

Event date
2026-04-15 00:00:00Z
Observed
2026-07-09 22:53:06Z
Source ID
Z-1795-2026
Payload hash
7919d446b3850a368ee19c8d…

Summary

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 a… Status: Ongoing.

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Informational only. Not legal, financial, or medical advice.