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Cleaner SCS

Siemens Healthcare Diagnostics Products GmbH · Model 10446136 · UDI-DI 00842768008153

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

Description

Cleaning solution BN II, BN ProSpec® Systems and BCS® Systems

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.