Discrete photometric chemistry analyzer for clinical use.
Recall
- Recall Number
- Z-2545-2024
- Event Number
- 94902
- Firm
- Beckman Coulter, Inc.
- FEI Number
- 2122870
- Product Code
- JJE
- Status
- Open, Classified
- Root Cause
- Under Investigation by firm
- Initiated
- June 14, 2024
- Posted
- August 9, 2024
- Address
- 1000 Lake Hazeltine Dr, Chaska, MN, 55318-1037
Description
Discrete photometric chemistry analyzer for clinical use.
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.
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.
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.
59 units