Discrete photometric chemistry analyzer for clinical use.

FDA device recall Z-2545-2024 · posted 2024-08-09 · Open, Classified

Recall details

Recalling firm

Beckman Coulter, Inc.

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.

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.

Root cause

Under Investigation by firm

Status

Open, Classified

Product code

JJE

Quantity affected

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, Switz

Date initiated

2024-06-14

Date posted

2024-08-09

Location

Chaska, MN