DxA 5000 Automation System Recalled Due to Sample Containment Defect
Beckman Coulter is recalling 123 DxA 5000 automation systems due to a sample containment defect that may cause samples to drop, delaying patient treatment and risking biohazard exposure. Affected units were distributed to eleven states.
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: FDA Class II medical device with high-risk bloodborne pathogen exposure (HIV, HBV, HCV) without reported illnesses or injuries. Per the rubric, high-risk pathogens without reported illness score as High.
Plain-English summary
Beckman Coulter Inc. is recalling 123 units of the DxA 5000 automation system, a laboratory device used for in vitro diagnostic testing. The recall affects specific serial numbers distributed across eleven states: Alabama, California, Illinois, Indiana, Kentucky, Minnesota, Michigan, Ohio, Pennsylvania, Texas, and West Virginia.
The device has a defect in its automated sampling system. Sample carriers may transport samples to an outer lane that lacks a physical barrier to contain them. When samples reach the end of this outer lane, they can drop.
This defect can delay diagnosis and patient treatment, as new samples must be drawn. Additionally, the dropped samples pose a risk of biohazard material discharge, potentially exposing personnel to transmissible blood-borne pathogens including HIV, hepatitis B virus (HBV), and hepatitis C virus (HCV).
Affected facilities should verify their system serial numbers against the FDA recall list and contact Beckman Coulter for corrective action.
The recalled product
- Product
- DxA 5000 (DxA Automation System, DxA 5000 fit), "For in Vitro Diagnostic Use", Reference Numbers: B87352 with B57634, UDI: 15099590707118
- Manufacturer
- Beckman Coulter Inc.
- Affected units
- 123
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)
- Affected US Serial Numbers: T23000077
- T23000075
- T23000076
- T23000074
- T23000069
- T23000070
- T23000066
- T23000099
- T23000096
- T23000098
- T23000100
- T23000095
- T23000097
- T23000101
- T23000092
- T23000091
- T23000090
- T23000142
- T23000045
- T23000040
Distribution
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