Beckman Coulter, Inc.: Medical Device Recall in 2025 - (Recall #: Z-0889-2026)

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 2 Reaction Vessels, individual, disposable, plastic tubes used to process patient, quality control and calibration samples on the Access 2 Immunoassay system, Catalog Number 81901

Product Classification:

Class II

Date Initiated: November 7, 2025
Date Posted: December 17, 2025
Recall Number: Z-0889-2026
Event ID: 97932
Reason for Recall:

It has been determined that certain lots of Access 2 Reaction Vessels may contain manufacturing deformities. The bottom (round end) of the Reaction Vessel may have a small protrusion or hair like deformity. This could cause causing instrument errors (e.g., pipetting, rake, wash carousel errors) that could delay patient results.

Status: Ongoing
Product Quantity: 38,225 untis
Code Information:

UDI-DI: 15099590180249; Lot Numbers: P243943, P243971, P244202 P244344, P244345, P250001, P250002, P250003, P250004 and P250005

Distribution Pattern:

US Nationwide. Global Distribution.

Voluntary or Mandated:

Voluntary: Firm initiated