FDA-Device2025-03-26Class II
Access 2 Immunoassay Analyzer, Catalog Number 81600N
Beckman Coulter, Inc.
Hazard
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.
Sold states
Worldwide - US Nationwide distribution.
Affected count
873 units
Manufactured in
1000 Lake Hazeltine Dr, N/A, Chaska, MN, United States
Products
Access 2 Immunoassay Analyzer, Catalog Number 81600N
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1386-2025Don't want to check this manually?
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