Immunoassay Analyzer Software Error May Cause Sample Result Mix-up
The DxI 9000 Access Immunoassay Analyzer may mix up test results from different patient samples. A software defect causes the system to replace current sample barcodes with previously-used IDs, potentially associating wrong results with wrong patients.
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 a Class II medical device recall involving a software defect that may cause test results to be incorrectly associated with patient samples. This represents a risk-of-harm scenario where erroneous laboratory results could affect patient care, but no illnesses or injuries have been reported.
Plain-English summary
Beckman Coulter, Inc. has recalled the DxI 9000 Access Immunoassay Analyzer (software versions 1.15 and below) due to a software defect affecting sample identification when the device is connected to a Laboratory Information System (LIS).
When connected to an LIS, the analyzer's software may ignore the barcode of the current sample and instead use a sample ID that was previously processed in the same rack position. This defect can cause results for the current sample to be delayed and may result in test results from one sample being incorrectly associated with a different patient's sample.
The recall affects 36 units distributed worldwide, including locations in Florida in the United States and in Croatia, Czechia, France, Germany, Ireland, Italy, Netherlands, New Zealand, South Africa, Spain, Switzerland, and the United Kingdom.
Healthcare facilities operating affected analyzers should contact Beckman Coulter for instructions on software updates or other corrective actions.
The recalled product
- Product
- DxI 9000 Access Immunoassay Analyzer, REF C11137, Sofware Versions 1.15 and below; invitro diagnostic
- Manufacturer
- Beckman Coulter, Inc.
- Affected units
- 36
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)
- UDI/DI 15099590732103
- All DxI 9000 Access Immunoassay Analyzer running software version 1.15 or prior
Distribution
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