Medical Analyzer Software Flaw Allows Use of Expired Calibrator
Beckman Coulter DxI 9000 immunoassay analyzers with software version 1.16.2 and prior can process orders using expired calibration material, potentially producing incorrect patient laboratory test results.
What this means for you
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. The defect creates a clear risk of patient harm through erroneous laboratory test results, which falls under the rubric criterion for Score 3: 'risk-of-harm products where injury has not yet been reported.'
Plain-English summary
The Beckman Coulter DxI 9000 Access Immunoassay Analyzer (REF #C11137) is an in vitro diagnostic device used in clinical laboratories to measure analyte concentrations in human body fluids. This recall affects 164 units with system software version 1.16.2 and prior.
When the analyzer is configured to automatically request calibration orders, the system can process those orders using expired calibrator material. If a calibration curve is generated with expired calibration material, the analyzer may produce erroneously high or low patient results, potentially leading to misdiagnosis or inappropriate treatment.
The affected devices were distributed to healthcare facilities in Florida, Georgia, Indiana, Kansas, New Hampshire, New Jersey, Oklahoma, Pennsylvania, and Texas, as well as internationally to Australia, Austria, Belgium, Brazil, Croatia, Czechia, Egypt, France, Germany, Hungary, Ireland, Israel, Italy, the Netherlands, New Zealand, Poland, Portugal, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, China, and the United Kingdom. Affected devices can be identified by serial number listed in the FDA recall notice.
The recalled product
- Product
- Beckman Coulter Dxl 9000 Access Immunoassay Analyzer, REF #C11137. An in vitro diagnostic device used for the quantitative, semi-quantitative, or qualitative determination of various analyte concentrations found in human body fluids.
- Manufacturer
- Beckman Coulter, Inc.
- Hazard
- calibration-error
- erroneous-lab-results
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 (19)
- UDI-DI: 15099590230623
- U.S. serial numbers: 300284
- 300286
- 300294
- 300266
- 300291
- 300223
- 300260
- 300285
- 300292
- 300195
- 300227
- 300228
- 300205
- 300207
- 300206
- 300182
- 300192
- and 300234. OUS serial numbers have been requested.
Distribution
Distributed in 9 states:
- FL
- GA
- IN
- KS
- NH
- NJ
- OK
- PA
- TX
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