RX Monaco-IVD Clinical Chemistry Analyzer rerun feature may report incorrect results
Randox Laboratories is recalling 13 RX Monaco-IVD Clinical Chemistry Analyzers with a rerun feature defect that may report incorrect test results when samples are outside normal assay range. Units were distributed nationwide including Puerto Rico.
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: FDA Class II recall with no reported illnesses or injuries. However, it involves a medical device that may report test results incorrectly, creating a risk of harm to patients from potential misdiagnosis.
Plain-English summary
Randox Laboratories Ltd. is recalling 13 RX Monaco-IVD Clinical Chemistry Analyzers (Catalog Number RX5000) due to a defect in the rerun feature. The affected units were distributed nationwide including Puerto Rico.
The rerun settings (specifically sample volume low/high and dilutions for automatic reruns) do not properly meet rerun conditions when samples are above or below the assay range. This defect may result in test results being reported incorrectly.
Healthcare facilities and laboratories that received affected units should verify their device lot numbers against the recall notice and contact Randox Laboratories if their equipment matches one of the identified batch numbers.
The recalled product
- Product
- RX Monaco-IVD Clinical Chemistry Analyser Catalog Number: RX5000
- Manufacturer
- Randox Laboratories Ltd.
- Affected units
- 13
Distribution
Part of a larger recall action
This product is one of 5 recalled by Randox Laboratories Ltd. 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.
See all 5 products in this recall →Related recalls
Same manufacturer · Randox Laboratories Ltd.
See all →- ModerateCystatin C Diagnostic Reagent Marketed Without FDA 510(k) Clearance
FDA (Devices) · 2024-07-31
- HighRandox Clinical Chemistry Calibration Serum Recalled for Measurement Bias
FDA (Devices) · 2024-05-15
- ModerateEvidence MultiSTAT analyzer foam gasket malfunction may affect test accuracy
FDA (Devices) · 2024-05-15
- HighMicroalbumin Calibrator Series Recalled for Negative Bias and Patient Result Misclassification
FDA (Devices) · 2024-04-24
- HighMicroalbumin Calibrator Series Recall Due to Measurement Accuracy Issue
FDA (Devices) · 2024-04-24
Same hazard · incorrect results
See all →- CriticalLibre 3 Plus sensors, REF 78769-01, recalled over carbon build up
FDA (Devices) · 2026-01-21
- CriticalGlucose monitoring sensors recalled over carbon build up causing low readings
FDA (Devices) · 2026-01-21
- CriticalLibre 3 Plus sensors recalled over carbon build up causing low readings
FDA (Devices) · 2026-01-21
- CriticalLibre 3 Plus sensors recalled in a second lot over carbon build up
FDA (Devices) · 2026-01-21
- HighSkin cancer aid recalled because it may not meet specifications
FDA (Devices) · 2025-12-03
Similar recalls
- ModerateRandox RX Imola Analyzers Recalled for Software Termination Issue
FDA (Devices) · 2018-06-13
- LowRandox Urinalysis Control Level 2 Recalled for Incorrect Leukocyte Range
FDA (Devices) · 2019-10-02
- ModerateRandox Calcium Reagent Recall for Potential Carryover Errors
FDA (Devices) · 2019-02-27
- LowRandox Immunoassay Premium Controls Recalled for Incorrect Analyzer Target Values
FDA (Devices) · 2019-04-17
- HighRandox RX Imola Analyzer Software Freeze Recall - 50 Units Affected
FDA (Devices) · 2021-07-14
- HighRandox Urea Enzymatic Assay Recall: Falsely Low Test Results Risk
FDA (Devices) · 2023-08-16