Beckman Coulter AU5800 Clinical Chemistry Analyzer Recalled for Software Error
Beckman Coulter is recalling 490 AU5800 Clinical Chemistry Analyzers due to a software error that may cause the system to misidentify samples and report erroneous patient 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: The recall is classified as FDA Class II. The hazard involves a risk of harm (erroneous patient results) due to a software defect, but the source text does not report any specific injuries, illnesses, or deaths, fitting the criteria for a High severity score.
Plain-English summary
Beckman Coulter, Inc. is recalling 490 units of the AU5800 Clinical Chemistry Analyzer. This automated in vitro diagnostic system is used to measure analytes in samples using various reagents and accessories. The recall affects specific model numbers (AU5811-01 through AU5841-06) equipped with software versions 4.11 and prior.
The recall was initiated because of a software error that has the potential to cause the reporting of erroneous patient results. This occurs because the AU5800 system may misidentify samples. The affected units were distributed worldwide, including in the United States, Canada, Puerto Rico, and numerous international locations.
Healthcare facilities and laboratories should contact Beckman Coulter for instructions on how to address the software error. The source text does not specify a consumer action for individual patients, as the product is intended for professional in vitro diagnostic use.
The recalled product
- Product
- AU5800 Clinical Chemistry Analyzer The Beckman Coulter AU5800 Clinical Chemistry Analyzer is an automated chemistry analyzer that measures analytes in samples, in combination with appropriate reagents, calibrators, quality control (QC) material and other accessories. This…
- Manufacturer
- Beckman Coulter Inc.
- Affected units
- 490
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 (20)
- AU5821-01
- AU5831-01
- AU5841-01
- AU5811-02
- AU5821-02
- AU5831-02
- AU5841-02
- AU5811-03
- AU5821-03
- AU5831-03
- AU5841-03
- AU5811-04
- AU5821-04
- AU5831-04
- AU5841-04
- AU5811-06
- AU5821-06
- AU5831-06
- AU5841-06 Part Numbers A94906
- A94911
Distribution
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