PlainRecalls
FDA Devices Moderate Class II Ongoing

Discrete photometric chemistry analyzer for clinical use.

Reported: August 21, 2024 Initiated: June 14, 2024 #Z-2545-2024

Product Description

Discrete photometric chemistry analyzer for clinical use.

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.

Details

Recalling Firm
Beckman Coulter, Inc.
Units 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, Switzerland, Vietnam.
Location
Chaska, MN

Frequently Asked Questions

What product was recalled?
Discrete photometric chemistry analyzer for clinical use.. Recalled by Beckman Coulter, Inc.. Units affected: 59 units.
Why was this product recalled?
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.
Which agency issued this recall?
This recall was issued by the FDA Devices on August 21, 2024. Severity: Moderate. Recall number: Z-2545-2024.