FDA recall Z-1913-2025

Beckman Coulter, Inc. · Class II · device

Product

DxI 9000 Access Immunoassay Analyzer, Catalog Number C11137, running software version 1.20

Reason for recall

A new software update (v1.20) is introducing error codes for the Dxl 9000 which prevents the assay from being performed and a delay in results from being generated, and may require field service to resolve the delay.

Distribution

Worldwide Distribution: US (Nationwide) and OUS (Global) to countries of: Kazakhstan, Spain, Germany, Italy, Belgium, Croatia, Taiwan, Province of China, Poland, India, Singapore, Switzerland, France, Libya, United Kingdom of Great Britain and Northern Irland, Oman, Algeria, Czechia, Korea, Public of, Slovakia, Croatia, Cote d'lvoire, Australia, Ireland, Taiwan, Province of China, New Zealand, Austria, Hungary, Brazil, Israel, Portugal.

Key facts

Status
Ongoing
Initiation date
2025-04-23
Report date
2025-06-11
Voluntary/Mandated
Voluntary: Firm initiated
Location
Chaska, MN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1913-2025