Beckman Coulter DxI 9000 immunoassay analyzer recalled for software-related motion errors
Beckman Coulter is recalling 61 DxI 9000 immunoassay analyzers worldwide due to a software error causing tray gripper motion errors that result in intermittent hard stops and delays in 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 an FDA Class II medical device recall where a software error causes operational failures (intermittent hard stops and delays) in a diagnostic analyzer. No injuries or illnesses have been reported, but the device's operational unreliability poses a risk to clinical workflow and patient testing. Per the rubric, this qualifies as a risk-of-harm product without reported injury, warranting High severity.
Plain-English summary
Beckman Coulter, Inc. is recalling 61 units of the DxI 9000 Access Immunoassay Analyzer (catalog number C11137). The analyzer is an in-vitro diagnostic device used for immunoassay testing. The recall affects devices distributed worldwide.
The recall was initiated due to a software error that causes an increase in tray gripper motion errors. These errors result in intermittent hard stops during device operation and delays in patient test results.
The affected devices have been distributed worldwide to the United States and to Australia, Austria, Brazil, Croatia, France, Germany, Hungary, India, Ireland, Italy, New Zealand, Portugal, Slovakia, Spain, Switzerland, Taiwan, China, and the United Kingdom. Affected units are identified by serial numbers from 300168 to 300228.
The recalled product
- Product
- Beckman Coulter DxI 9000 Access Immunoassay Analyzer, catalog number C11137; in-vitro diagnostic instrument
- Manufacturer
- Beckman Coulter, Inc.
- Affected units
- 61
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)
- UDI/DI 15099590732103
- serial numbers: 300208
- 300201
- 300184
- 300185
- 300169
- 300225
- 300175
- 300172
- 300221
- 300209
- 300211
- 300212
- 300213
- 300214
- 300215
- 300210
- 300174
- 300226
- 300204
Distribution
Distributed nationwide across the United States.
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