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IDS-iSYS Insulin-like Growth Factor Binding Protein 3 (IGFBP-3)

IMMUNODIAGNOSTIC SYSTEMS LIMITED · Model IS-4400 · UDI-DI 05060169690301

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510(k) clearances

Adverse events

Recalls

Facilities

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.
2016-04-15	Siemens Healthcare Diagnostics, Inc.	24 minutes of incubation is required prior to processing patient samples and for the pretreatment solution to reach full equilibration when using pretreatment solution when using t
2011-03-30	Beckman Coulter Inc.	The recall was was initiated because patient results with the IGFBP-3 ELISA kit may be elevated by 70% compared to stated expected ranges in the Instructions for Use (IFU).
2010-08-09	Beckman Coulter Inc.	The recall was initiated after Beckman Coulter confirmed customer reports that IGFBP-3 measurements using IGFBP-3 IRMA kit (REF DSL-6600) lots identified above may result in IGFBP-
2005-05-02	Nichols Institute Diagnostics	Under recovery of diluted samples by as much as 20%.

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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.