Medical Device Recall: Discrete photometric chemistry analyzer for clinical use.
Beckman Coulter, Inc. · June 14, 2024
Reason for Recall
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.
Distribution
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.
States Affected
NATIONWIDE
Quantity Affected
59 units
Source: FDA (openFDA Device Enforcement)
Recall number: Z-2545-2024
Status: ongoing
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