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IMMULITE®/IMMULITE® 1000 Systems PAP
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD · Model 10380953 · UDI-DI 00630414964355
1
510(k) clearances
0
Adverse events
1
Recalls
9
Facilities
Description
PAP - IMMULITE - RGT - 100 Tests
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2018-03-05 | Tosoh Bioscience Inc | Asfotase 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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Get your free API keyRead the docsData 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.