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IMMULITE® 2000 Systems PAP

SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD · Model 10380975 · UDI-DI 00630414961804

JFH
1
510(k) clearances
0
Adverse events
1
Recalls
9
Facilities

Description

PAP - IMMULITE - RGT - 200 Tests

Recalls

DateFirmReason
2018-03-05Tosoh Bioscience IncAsfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely increased or falsely decreased immunoassay test results, depending upon the assay.

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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.