Clinical Chemistry Analyzer Recalled for Software Defect in Test Result Calculation
Beckman Coulter is recalling certain DxC 500 AU Clinical Chemistry Analyzers due to a software defect that prevents calculated test results from being recalculated when constituent tests are rerun, potentially delaying patient result reporting.
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 with a software defect affecting diagnostic result calculation and reporting. No illnesses or injuries have been reported. Per the FDA severity rubric, risk-of-harm products without documented injury are classified as High.
Plain-English summary
Beckman Coulter Inc. is recalling DxC 500 AU Clinical Chemistry Analyzers with software versions V1.3, V1.4, V1.4.1, V1.4.2, and V1.4.3. The analyzer is an automated device used in clinical laboratories to measure patient samples and calculate diagnostic test results.
A software defect in these versions prevents the analyzer from recalculating results when constituent tests are rerun. When tests are rerun manually by operators or automatically by system rules, the analyzer fails to regenerate calculated results based on the new test data. Instead, it reports the calculated result from the original tests. This defect may cause delays in reporting patient results.
The recall affects 143 analyzers distributed worldwide: 74 units in the United States and 69 units internationally to countries including Australia, Belgium, Canada, France, Germany, India, Italy, South Korea, Netherlands, Philippines, Poland, and others.
Facilities using affected analyzers should contact Beckman Coulter for information about software updates. Users can identify affected devices by checking the catalog numbers (C63519 and C63520) and serial numbers listed on the FDA recall notice.
The recalled product
- Product
- DxC 500 AU Clinical Chemistry Analyzer, Catalog Numbers/UDI codes: C63519 / 14987666545058 C63520 / 14987666545065 The Beckman Coulter DxC 500 AU Clinical Chemistry Analyzer is an automated chemistry analyzer that measures analytes in samples, in combination with appropriate
- Manufacturer
- Beckman Coulter Inc.
- Hazard
- software-defect
- incorrect-calculation
- delayed-reporting
Distribution
Distributed nationwide across the United States.
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