Recall Z-2545-2024
Beckman Coulter, Inc. · initiated June 14, 2024
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Discrete photometric chemistry analyzer for clinical use.
Codes / lots: 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
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.
FDA-determined cause: Under Investigation by firm
Action taken
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.
Details
- Recall number
- Z-2545-2024
- Initiated
- June 14, 2024
- Posted by FDA
- August 9, 2024
- Product code
- JJE – Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
- Quantity
- 59 units
- 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.
- Recalling firm
- Beckman Coulter, Inc., Chaska, MN