Beckman Coulter, Inc.: Medical Device Recall in 2025 - (Recall #: Z-0803-2025)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2025.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: November 26, 2024

Date Posted: January 15, 2025

Recall Number: Z-0803-2025

Event ID: 95871

Reason for Recall:

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.

Status: Ongoing

Product Quantity: 362 units

Code Information:

UDI: (01)15099590201937(17)241130(11)231201; Lot 339071

Distribution Pattern:

Worldwide distribution - US Nationwide and the country of Canada.

Voluntary or Mandated:

Voluntary: Firm initiated