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.
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. Quantity: 59 units Lot/code info: Catalog Number: 81600N, C11907; UDI: 150995901; Serial Numbers: 574415, 574440, 574484,574416, 574441, 574485, 574417, 574442, 574486, 574418, 574443, 574488,574419, 574444, 574489,574420, 574445, 574490, 574421, 574446, 574491, 574422, 574447 574494,574423, 574448, 574497,574424, 574454, 574502, 574425, 574455, 574503, 574426, 574456 574504,574427, 574457, 574505,574428, 574459, 574506, 574429, 574469, 574507, 574430, 574470 574509,574432, 574471, 574513, 574433, 574472, 574514, 574434, 574477, 574515, 574435, 574479
Official record: FDA (Device enforcement) ↗
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