Access 2 Reaction Vessels, individual, disposable, plastic tubes used to process patient, quality...
FDA Recall #Z-0889-2026 — Class II — November 7, 2025
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
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.
Recalling Firm
Beckman Coulter, Inc. — Chaska, MN
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
38,225 untis
Distribution
US Nationwide. Global Distribution.
Code Information
UDI-DI: 15099590180249; Lot Numbers: P243943, P243971, P244202 P244344, P244345, P250001, P250002, P250003, P250004 and P250005
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated