RX Imola Clinical Chemistry Analyzer rerun feature may report results incorrectly
RX Imola-IVD Clinical Chemistry Analyzers may report test results incorrectly when handling out-of-range samples due to improper parameter rerun settings. 35 units nationwide are affected.
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 recall of a clinical laboratory device with potential to report incorrect test results for out-of-range samples. While no injuries or illnesses are reported, the risk of incorrect laboratory results affecting patient diagnoses and treatment warrants a High severity rating per the risk-of-harm criterion.
Plain-English summary
Randox Laboratories Ltd. is recalling the RX Imola-IVD Clinical Chemistry Analyzer (Catalog Number RX4900 and RX4900R refurbished, GTIN: 05055273206104). This medical device is used in clinical laboratories to perform chemical analyses. A total of 35 units have been recalled.
The analyzer's parameter rerun settings for sample volume (Low/High) and dilutions used for automatic reruns do not properly meet sample re-run conditions when test samples fall above or below the assay range. This may result in issues with the rerun feature and the potential for the analyzer to report incorrect test results.
The affected units were distributed nationwide in the United States, including Puerto Rico. Specific lot and batch numbers have been identified by the FDA. Laboratories that have received these units should contact Randox Laboratories Ltd. for guidance on corrective actions or device replacement.
The recalled product
- Product
- RX Imola-IVD Clinical Chemistry Analyzer Catalog Number: RX4900. RX4900R (refurbished)
- Manufacturer
- Randox Laboratories Ltd.
- Hazard
- incorrect-test-results
- assay-accuracy
Distribution
Distributed nationwide across the United States.
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