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Pointe Scientific, Inc.

HORIBA INSTRUMENTS INCORPORATED · Model HA703-60 · UDI-DI 00811727012210

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510(k) clearances

Adverse events

Recalls

Facilities

Description

Acid Phosphatase Reagent Set for the quantitative determination of acid phosphatase in serum on Hitachi analyzers. For in vitro diagnostic use only. Packaged at 6 x 10ml

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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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.