Chemistry Analyzer (Beckman Coulter) - Carousel Motion Error (2024)
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Discrete photometric chemistry analyzer for clinical use.
Brand
Beckman Coulter, Inc.
Lot Codes / Batch Numbers
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
Products Sold
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
Beckman Coulter, Inc. is recalling Discrete photometric chemistry analyzer for clinical use. due to Beckman Coulter, Inc. has identified a rise in reagent carousel motion errors in Access 2 Immunoassay System Analyzers that appear to be caused by mis. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
The recall notification was sent to consignees during the week of 06/14/2024 via email and postal mail. Consignees were instructed to follow the troubleshooting instructions in section 6.4 of the Access 2 Reference Manual and contact the Beckman Coulter representative if the laboratory has experienced repeated reagent carousel motion or QSMC errors. Consignees are asked to respond within 10 days indicating they have received the important communication either via by email or by returning the response form.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026