Clinical chemistry analyzer modules recalled over stalled test status and delays
Beckman Coulter is recalling 116 DxC 500 AU modules because a clinical chemistry sample can remain In Progress with no error when an immunoassay test is processed between chemistry tests.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: Scored 2 because the stated consequence is a processing delay rather than an erroneous result, with no injury reported.
Plain-English summary
DxC 500 AU Modules with ISE (REF C63522) and without ISE (REF C63521), part of the DxC 500i Clinical Analyzer, are being recalled for a defect in software versions 1.3.3 and 1.3.4.
When a clinical chemistry combination test is ordered at the same time as an immunoassay test, and the immunoassay test is processed between the chemistry tests, the chemistry sample status remains "In Progress" with no errors shown. This may cause processing delays.
The recall covers 116 units, distributed internationally to countries including Poland, India, the Dominican Republic, Lebanon, Italy, Brazil and El Salvador. The FDA has classified the action as Class II.
The enforcement record describes a delay rather than an incorrect result. Laboratories running the affected software versions should follow Beckman Coulter's instructions.
The recalled product
- Product
- DxC 500 AU Module w/ISE, DxC 500i, With ISE, REF: C63522 and DxC 500 AU Module, DxC 500i, Without ISE, REF: C6352; part of the DxC 500i Clinical Analyzer
- Manufacturer
- Beckman Coulter Inc.
- Affected units
- 116
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 (2)
- REF/UDI-DI: C63522/14987666545089
- C63521/14987666545072. Software Versions: SW 1.3.3 and 1.3.4
Distribution
Distribution scope not specified by the agency.
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