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Access C-Peptide

Beckman Coulter, Inc. · Model C33451 · UDI-DI 15099590733377

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510(k) clearances

Adverse events

Recalls

Facilities

Description

The Access C-Peptide assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of C-Peptide levels in human serum, plasma and urine using the Access Immunoassay Systems as an aid in the diagnosis and treatment of patients suspected of having diabetes or other insulin secretion disorders.

Recalls

Date	Firm	Reason
2021-12-21	DRG International, Inc.	ODs of the standards too low(< 0.6 ODmax) may cause invalid runs, delayed patient results are possible
2020-04-01	Abbott Laboratories	Error in the renewal documentation process for license in Mexico. All in date ARCHITECT C Peptide Reagents, Calibrators and Controls are being recalled until a new license is obtai
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.
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.
2011-07-11	Abbott Laboratories	C-Peptide lots 03610K000 and 01711A000 have the potential to generate falsely elevated results with certain patient samples and with non-Abbott Controls.

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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.