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Beckman Coulter, Inc. recalls Access Intact PTH assay, a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of int

Recalled January 15, 2025 · FDA recall Z-0803-2025 · Beckman Coulter

Hazard
Beckman Coulter has identified that some Access PTH reagent packs from lot 339071 may be over- or under-filled in well 0. The dispensed material in well 0 could be above or below specification, risking sealing issues, contamination, instrument errors, delays, or inaccurate results with a negative bias and increase in imprecision. The issue was confirmed on 10 April 2024 by Beckman Coulter through an internal non-conformance (NC-INT-66585). The well 0 scale on the filling line began malfunctioning on the fill immediately before PTH. The malfunction was not noticed until the majority of PTH was filled. · FDA Class II
Units
362 units
Sold at
Worldwide distribution - US Nationwide and the country of Canada.

Description

Beckman Coulter has identified that some Access PTH reagent packs from lot 339071 may be over- or under-filled in well 0. The dispensed material in well 0 could be above or below specification, risking sealing issues, contamination, instrument errors, delays, or inaccurate results with a negative bias and increase in imprecision. The issue was confirmed on 10 April 2024 by Beckman Coulter through an internal non-conformance (NC-INT-66585). The well 0 scale on the filling line began malfunctioning on the fill immediately before PTH. The malfunction was not noticed until the majority of PTH was filled.

Product
Access Intact PTH assay, a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of intact parathyroid hormone (parathyrin, PTH) levels in human serum and plasma using the Access Immunoassay Systems, Catalog Number A16972
Manufacturer(s)
Beckman Coulter, Inc.

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →