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Biobase Biodustry(Shandong)Co., Ltd. · Model BK-SPA120 · UDI-DI 06936895301660

JZW
10
510(k) clearances
35
Adverse events
1
Recalls
11
Facilities

Recalls

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

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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.