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B.R.A.H.M.S PCT sensitive KRYPTOR

B.R.A.H.M.S GmbH · Model 825.050 · UDI-DI 04260157638259

PMTNTMPRI Prescription
1
510(k) clearances
13
Adverse events
1
Recalls
21
Facilities

Recalls

DateFirmReason
2017-12-22Roche Diagnostics CorporationProduct exhibits a decreased recovery of patient samples on the cobas e 801 module compared to the MODULAR ANALYTICS E 170, cobas e 411, 601, and 602 analyzers.

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Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.