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BN ProSpec® System

Siemens Healthcare Diagnostics Products GmbH · Model 10465217 · UDI-DI 00630414002736

JZW
1
510(k) clearances
35
Adverse events
1
Recalls
11
Facilities

Description

The BN ProSpec® is a system for the quantitative determination of proteins in serum, plasma, urine and CSF

Recalls

DateFirmReason
2019-06-27Siemens Healthcare Diagnostics, Inc.Iincreased (falsely elevated) Albumin results compared to expected results

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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.