Beckman Coulter DxC 500 AU Clinical Chemistry Analyzer Recall
Beckman Coulter is recalling certain DxC 500 AU Clinical Chemistry Analyzers due to incorrect sample barcode identification and processing errors that can result in erroneous and delayed test 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 involving a medical device that can produce incorrect patient test results, which represents a risk of harm. No reported injuries or illnesses are mentioned in the source text, but the potential for diagnostic errors affecting patient care justifies a High severity rating.
Plain-English summary
Beckman Coulter Inc. is recalling the DxC 500 AU Clinical Chemistry Analyzer, a medical device used to measure analytes in patient samples. The recall affects Catalog Numbers C63519 and C63520, with specified serial numbers and software versions V1.3 through V1.4.3.
The reason for the recall is incorrect sample barcode identification and processing errors that result in the reporting of erroneous and delayed results. These errors could affect patient test results if not identified.
A total of 136 systems have been distributed: 68 in the United States and 68 internationally. U.S. distribution includes devices in Alabama, California, Colorado, Georgia, Idaho, Illinois, Indiana, Louisiana, Massachusetts, Michigan, Minnesota, Mississippi, Montana, North Carolina, New Mexico, Nevada, New York, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, Tennessee, Texas, Washington, and Wisconsin.
Healthcare facilities and laboratories with affected devices should contact Beckman Coulter Inc. for information on how to obtain a software update or device replacement. Facilities should review their testing procedures to ensure patient results have not been affected by this issue.
The recalled product
- Product
- DxC 500 AU Clinical Chemistry Analyzer, Catalog Numbers/UDI codes: C63519 / 14987666545058 C63520 / 14987666545065 Software versions: V1.3, V1.4, V1.4.1, V1.4.2, V1.4.3 The Beckman Coulter DxC 500 AU Clinical Chemistry Analyzer is an automated chemistry analyzer that…
- Manufacturer
- Beckman Coulter Inc.
Distribution
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