Immunoassay analyzers recalled over dilution factor anomaly affecting patient results
Beckman Coulter is recalling 571 DxI 9000 Access Immunoassay Analyzers over a software anomaly that may not apply user-specified manual dilution factors, risking false low or high 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: Scored 3 under the risk-of-harm criterion: the firm states the anomaly can produce false low or high patient results, and no injuries are reported.
Plain-English summary
The DxI 9000 Access Immunoassay Analyzer, part number C11137, is being recalled.
Beckman Coulter has confirmed a software anomaly on the DxI 9000 Access Immunoassay Analyzer and the DxC 500i Clinical Analyzer that may prevent correct application of user-specified manual dilution factors when additional tests are ordered for samples already "In Progress" using the same Sample ID number. The firm states this can lead to false low or high patient results and potential delays in reporting.
The recall covers 571 units carrying UDI-DI 15099590732103, distributed worldwide including nationwide in the United States. The FDA has classified the action as Class II.
Laboratories running affected serial numbers should follow Beckman Coulter's instructions.
The recalled product
- Product
- DxI 9000 Access Immunoassay Analyzer, Part Number C11137
- Manufacturer
- Beckman Coulter, Inc.
- Affected units
- 571
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 (1)
- C11137 UDI-DI: 15099590732103
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Beckman Coulter, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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