FDA-Device2025-12-17Class II
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.
Hazard
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.
Sold states
US Nationwide. Global Distribution.
Affected count
38,225 untis
Manufactured in
1000 Lake Hazeltine Dr, N/A, Chaska, MN, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0889-2026Don't want to check this manually?
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