FDA recall Z-1386-2025

Beckman Coulter, Inc. · Class II · device

Product

Access 2 Immunoassay Analyzer, Catalog Number 81600N

Reason for recall

Beckman Coulter identified that an issue for Access 2 Sample Motors (B48016) due to improper alignment, causing the motors to rub against the sample wheelbase plate and index sensor. The issue was traced to a worn tool used in production (at the supplier), affecting Access 2 sample motors. This could lead to a potential delay in reporting patient test results.

Distribution

Worldwide - US Nationwide distribution.

Key facts

Status
Ongoing
Initiation date
2025-02-05
Report date
2025-03-26
Voluntary/Mandated
Voluntary: Firm initiated
Location
Chaska, MN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1386-2025