FDA-Device2024-08-21Class II
Discrete photometric chemistry analyzer for clinical use.
Beckman Coulter, Inc.
Hazard
Beckman Coulter, Inc. has identified a rise in reagent carousel motion errors in Access 2 Immunoassay System Analyzers that appear to be caused by misaligned index wheels housed within the reagent carousel module. Customers affected by this issue may observe an increase in reagent carousel motion errors or QSMC errors that occur while unloading or loading reagent packs during system initialization and sample processing, which causes a non-operational system status and cancels tests; and patient results may be delayed if these errors cancel test processing.
Sold states
Worldwide - US Nationwide distribution in the states of NE, MT, LA, TX, NY, CA, MI, AL, IL the countries of Austria, Belgium, Georgia, India, Indonesia, Italy, Korea, Malaysia, Myanmar, Nigeria, Switzerland, Vietnam.
Affected count
59 units
Manufactured in
1000 Lake Hazeltine Dr, Chaska, MN, United States
Products
Discrete photometric chemistry analyzer for clinical use.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2545-2024Don't want to check this manually?
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