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IMMULITE®/IMMULITE® 1000 Systems GAS Gastrin

SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD · Model 10380962 · UDI-DI 00630414964034

CGC
10
510(k) clearances
3
Adverse events
2
Recalls
4
Facilities

Description

Gastrin - IMMULITE - RGT - 100 Tests

Recalls

DateFirmReason
2018-01-02Siemens Healthcare Diagnostics, Inc.Concentrations for the level of biotin that does not interfere is not currently listed in the instruction for use for the Dimension Vista CTNI, Dimension Vista MMB, Dimension Sirol
2018-01-02Siemens Healthcare Diagnostics, Inc.Concentrations for the level of biotin that does not interfere is not currently listed in the instruction for use for the Dimension Vista CTNI, Dimension Vista MMB, Dimension Sirol

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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.