RX Series Copper Assay Requires Modified Testing Order
Randox Laboratories issued a technical bulletin stating that RX Series Copper Assay tests must not be run directly after Total Protein tests, as this could produce falsely elevated copper 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: FDA Class II medical device recall affecting the accuracy of clinical laboratory test results. While no illnesses or injuries have been reported, this represents a risk-of-harm scenario: falsely elevated copper results could lead to patient misdiagnosis and inappropriate treatment. Per the rubric, risk-of-harm products without reported injuries are scored at 3 (High).
Plain-English summary
Randox Laboratories has released an updated Carryover Avoidance Technical Bulletin for the RX Series Copper (Cu) Assay (Ref. Number CU2340). The bulletin specifies that copper assays must not be run directly after Total Protein assays on RX series instruments, as this testing order could result in falsely elevated copper test results.
This notification affects clinical and reference laboratories using RX Series instruments with copper assay reagent. Laboratories should immediately review the updated technical bulletin and modify their testing protocols to ensure copper assays are not run directly following total protein assays, preventing inaccurate results that could affect patient diagnosis and treatment decisions.
Approximately 3,053 kits have been distributed, with units in the United States (South Carolina and Oklahoma) and internationally. Affected products carry lot/batch numbers 592278, 610661, 610669, 629021, 647201, and 657944. Laboratories currently using affected reagent batches should implement the required testing order modification without delay.
The recalled product
- Product
- RX Series Copper (Cu) Assay Ref. Number CU2340
- Manufacturer
- Randox Laboratories Ltd.
- Hazard
- inaccurate-test-results
- testing-methodology-error
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 (7)
- Catalogue Number/GTIN: CU2340 05055273201949
- Lot/batch: 592278
- 610661
- 610669
- 629021
- 647201
- 657944
Distribution
Distributed nationwide across the United States.
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