Class II
Medical Device Recall: 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
Beckman Coulter, Inc. · November 7, 2025
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.
Distribution
US Nationwide. Global Distribution.
States Affected
NATIONWIDE
Quantity Affected
38,225 untis
Source: FDA (openFDA Device Enforcement)
Recall number: Z-0889-2026
Status: ongoing
SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.