Dxl 9000 Immunoassay Analyzer Recalled for Corrosion of USB Cable Contacts
Beckman Coulter is recalling 143 Dxl 9000 Immunoassay Analyzers due to nonconforming USB cables with brass instead of gold contacts. Brass may corrode, potentially disabling internal communication and delaying patient 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 a Class II medical device recall involving a risk-of-harm product. The nonconforming USB cables could cause loss of internal communication and failure of diagnostic analyzers, potentially impacting patient care. Although no illnesses or injuries have been reported, the potential for analyzer malfunction represents a significant clinical risk.
Plain-English summary
Beckman Coulter, Inc. is recalling 143 Dxl 9000 Access Immunoassay Analyzer devices (Catalog #C11137) due to nonconforming USB cables. The cables were manufactured with brass contacts instead of the specified gold contacts.
Brass contacts may corrode over time, potentially causing loss of internal instrument communication and delayed patient test results. This defect affects the analyzer's ability to process samples reliably.
The affected devices were distributed worldwide, including throughout the United States (Florida, Indiana, Kansas, New Hampshire, Pennsylvania, and Texas) and to 22 additional countries. A complete list of affected serial numbers is available in the FDA recall notice.
Healthcare facilities and laboratories should identify affected equipment using the serial number list on the FDA's website. Beckman Coulter will provide remedial actions, which may include replacement USB cables or other corrective measures. Users with questions should contact Beckman Coulter directly.
The recalled product
- Product
- Dxl 9000 Access Immunoassay Analyzer, Catalog #C11137.
- Manufacturer
- Beckman Coulter, Inc.
- Affected units
- 143
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)
- Serial numbers: 300117
- 300116
- 300137
- 300138
- 300139
- 300129
- 300141
- 300143
- 300142
- 300151
- 300152
- 300128
- 300156
- 300153
- 300154
- 300135
- 300164
- 300180
- 300155
- 300167
Distribution
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