Immunoassay analyzer software may delay test processing with automation systems
A software issue in DxI 9000 Access analyzers connected to laboratory automation systems may prevent processing of all samples, flagging tests as timed out and potentially delaying patient results.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall of a laboratory diagnostic device with no reported illnesses or injuries. However, the software issue creates a risk of delayed test reporting which could delay patient treatment—fitting the rubric criterion of 'risk-of-harm products where injury has not yet been reported.'
Plain-English summary
The DxI 9000 Access Immunoassay Analyzer, manufactured by Beckman Coulter, Inc., is an automated laboratory device that performs clinical immunoassay tests. When running software version 1.17.0 or below and connected to a Laboratory Automation System (LAS), the analyzer does not send a notification to the LAS when its sample wheel reaches capacity. As a result, the LAS continues to send samples for processing despite the analyzer's limited capacity.
When this issue occurs, sample tests may be prepared for testing but not actually processed if the total number of tests exceeds the analyzer's throughput limit. These unprocessed tests are flagged with a sample wheel timeout (SWT) error, and reporting of test results may be delayed. Delays in reporting could impact the timing of clinical decisions about patient treatment.
Approximately 183 analyzers have been distributed to facilities in 12 U.S. states and multiple countries worldwide. The recall affects analyzers with UDI-DI 15099590732103 running software versions 1.17.0 or below.
The recalled product
- Product
- DxI 9000 Access Immunoassay Analyzer, Catalog #C11137.
- Manufacturer
- Beckman Coulter, Inc.
- Affected units
- 183
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Software versions 1.17.0 or below
- UDI-DI 15099590732103.
Distribution
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