DxI 9000 Access Immunoassay Analyzer calibration system error recall
Beckman Coulter is recalling the DxI 9000 Access Immunoassay Analyzer C11137 due to calibration issues where curves switch from passed to failed status due to system errors, potentially causing erroneous 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 an FDA Class II recall of a medical device that could produce erroneous diagnostic test results and delay detection of failures, creating risk of harm to patients relying on test data for clinical decisions. Although no illnesses or injuries are reported in the source text, the hazard (invalid test results affecting clinical decisions) is concrete and presents significant potential for adverse health consequences.
Plain-English summary
Beckman Coulter, Inc. is recalling the DxI 9000 Access Immunoassay Analyzer C11137 due to a calibration defect. The analyzer can experience calibration curves that switch from passed to failed status due to system errors occurring during aspiration.
This anomaly causes the analyzer to produce erroneous results and may cause test processing delays if the error goes unnoticed. Additionally, RLU (relative light unit) values may be misinterpreted as valid measurements by a Laboratory Information System (LIS), potentially resulting in the use of invalid test data in clinical decision-making.
The affected units were distributed worldwide to 67 locations in the US, including Arkansas, California, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Kentucky, Louisiana, Maine, Michigan, New Hampshire, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Dakota, Tennessee, Texas, Washington, and Wisconsin, as well as to 178 locations outside the US in countries including Algeria, Australia, Austria, Belgium, Brazil, Côte d'Ivoire, Croatia, Czechia, France, Germany, Hungary, India, Ireland, Israel, Italy, Kazakhstan, Korea, Libya, New Zealand, Oman, Poland, Portugal, Singapore, Slovakia, Spain, Sweden, Switzerland, Taiwan, and the United Kingdom.
Healthcare facilities and laboratories using affected analyzers should review their calibration status and test results to identify any tests affected by this issue. Contact Beckman Coulter, Inc. for guidance on remediation steps and instructions for identifying affected units by serial number.
The recalled product
- Product
- DxI 9000 Access Immunoassay Analyzer C11137
- Manufacturer
- Beckman Coulter, Inc.
Distribution
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