DxI 9000 Access Immunoassay Analyzer, REF C11137, Sofware Versions 1.15 and below; invitro diagnostic

FDA device recall Z-0107-2024 · posted 2023-10-12 · Open, Classified

Recall details

Recalling firm

Beckman Coulter, Inc.

Reason for recall

The firm has investigated and confirmed that when DxI 9000 is connected to Laboratory Information System (LIS, host), the sample barcode presented may be ignored and replaced with a sample ID that was previously in the same rack and position. This will cause a delay of result to the sample currently presented to the system (Sample B) and may result in an erroneous test result for the prior sample (Sample A), which gets associated with the results of sample B.

Action taken

Beckman Coulter notified its consignees on 09/12/2023 via letter. The notice explained the issue, risk, and consignees were advised to perform a retrospective review of all results that were generated on a DxI 9000 analyzer that is connected to a host system (laboratory information system or middleware). Current customers should perform one of the following: Option 1: Disconnect the DxI 9000 Access Immunoassay Analyzer from the host system. You may continue ordering tests through the analyzer console. Option 2: Prevent the host system from downloading test orders or sending new information updates to the analyzer. Beckman Coulter will release system software version 1.15.2, which prevents reporting an erroneous test result. Test results will still be delayed when the DxI 9000 Access Immunoassay Analyzer may incorrectly identify samples.

Root cause

Software design

Status

Open, Classified

Product code

JJE

Quantity affected

36 units

Distribution

Worldwide - US Nationwide distribution in the state of Florida, and the countries of Croatia, Czechia, France, Germany, Ireland, Italy, Netherlands, New Zealand, South Africa, Spain, Switzerland, Unit

Date initiated

2023-09-12

Date posted

2023-10-12

Location

Chaska, MN

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