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Access Total BhCG (5th IS)

Beckman Coulter, Inc. · Model C28645 · UDI-DI 15099590744380

DHA Prescription

510(k) clearances

3,587

Adverse events (1 deaths)

Recalls

Facilities

Description

The Access Total BhCG (5th IS) assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of total BhCG levels in human serum and plasma using the Access Immunoassay Systems. This assay is intended for use as an aid in the early detection of pregnancy.

Recalls

Date	Firm	Reason
2022-11-24	Abbott Laboratories	Reaction vessels may contain a potential contaminant that could affect their optical performance.
2022-02-22	Siemens Healthcare Diagnostics, Inc.	Potential for falsely elevated hCG results due to sample carryover in serum and urine patient samples, as well as quality control samples and adjustors.
2018-11-21	Abbott Ireland Diagnostics Division	Abbott has become aware of a manufacturing issue that can result in damage to a bottle neck in some of the reagent cartridges found in the lots listed in Appendix A. If a bottle n
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.
2016-02-18	Ortho-Clinical Diagnostics	When testing was conducted using certain lots, VITROS Systems generated results within the measuring range for samples known to not contain measurable hCG. The system reported resu
2015-11-11	Siemens Healthcare Diagnostics Inc	Stratus CS Cartridge Barcode labels may not scan on the Stratus CS systems
2015-11-11	Siemens Healthcare Diagnostics Inc	Stratus CS Cartridge Barcode labels may not scan on the Stratus CS systems
2010-12-22	BioCheck Inc	Product labels indicate that the products are for IVD use and they do not have an approved 510(k).
2010-12-22	BioCheck Inc	Product labels indicate that the products are for IVD use and they do not have an approved 510(k).
2006-04-03	Dade Behring , Inc.	Foil sealing of the DilPak may occlude the pipet tip resulting in insufficient aspiration of fluids. Erroneous test results may be generated without an associated error code. Tes

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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.