FDA recall Z-0889-2026

Beckman Coulter, Inc. · Class II · device

Product

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.

Distribution

US Nationwide. Global Distribution.

Key facts

Status
Ongoing
Initiation date
2025-11-07
Report date
2025-12-17
Voluntary/Mandated
Voluntary: Firm initiated
Location
Chaska, MN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0889-2026