Clinical analyzer modules recalled over dilution factor software anomaly affecting results
Beckman Coulter is recalling 160 DxC 500i Clinical Analyzer modules over a software anomaly that may not apply user-specified manual dilution factors, risking false low or high results.
What this means for you
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
DxC 500i Clinical Analyzer Modules are being recalled, covering the DxC 500 AU Module with ISE (part number C63522), the DxC 500 AU Module (C63521) and the Access 2 Module (C13252).
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 160 units, 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
- DxC 500i Clinical Analyzer Modules, DxC 500 AU Module w/ISE, DxC 500i (Part Number C63522), DxC 500 AU Module, DxC 500i (Part Number C63521), and Access 2 Module, DxC 500i (Part Number C13252)
- Manufacturer
- Beckman Coulter, Inc.
- Affected units
- 160
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 (3)
- C63522 UDI-DI: 14987666545089
- C63521 UDI-DI: 14987666545072
- C13252 UDI-DI: 15099590742331
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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