Randox RX Imola Analyzers Recalled for Software Termination Issue
Randox Laboratories is recalling 41 RX Imola analyzers because a software defect may cause premature termination, delaying patient test results.
What this means for you
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: The recall is classified as FDA Class II. The hazard is a delay in reporting test results due to software termination, with no reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Randox Laboratories is recalling 41 units of the RX Imola (RX4900) analyzer. These devices are used for professional in vitro determination of various clinical chemistry tests. The recall involves all serial numbers associated with GTIN 05055273206104.
The recall is due to a software defect that may cause abnormal premature termination. This issue could affect the use of the analyzer when running patient samples, resulting in a delay in reporting test results. No injuries or illnesses have been reported in the source text.
The affected units were distributed in the United States, including Puerto Rico and the state of West Virginia. Users of these devices should contact Randox Laboratories for instructions on how to address the software issue.
The recalled product
- Product
- RX Imola (RX4900) For Professional Use for the quantitative in vitro determination of various clinical chemistry tests.
- Manufacturer
- Randox Laboratories
- Affected units
- 41
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 (1)
- GTIN 05055273206104. All serial numbers.
Distribution
Related recalls
Same manufacturer · Randox Laboratories
See all →- HighCRP Immunoturbidimetric Reagent Recalled for Positive Bias in Patient Samples
FDA (Devices) · 2023-04-05
- LowRandox Immunoassay Premium Plus Controls Recalled for Stability Issues
FDA (Devices) · 2018-03-21
- LowRandox Recalls Immunoassay Premium Controls Due to Stability Claim Failure
FDA (Devices) · 2018-03-21
- LowRandox Liquid Urine Control Level 3 Recalled for Labeling Error
FDA (Devices) · 2017-06-07
- ModerateRandox Liquid Cardiac Controls Recalled for Decreased Analyte Recovery
FDA (Devices) · 2016-12-21
Same hazard · software defect
See all →- HighMidmark IQecg Digital ECG Software Recall for Inaccurate Waveforms
FDA (Devices) · 2026-09-02
- HighMidmark Digital ECG Software Recall for Incorrect Waveform Display
FDA (Devices) · 2026-09-02
- ModerateEndoFLIP System Recall Due to Incorrect Catheter Expiration Flags
FDA (Devices) · 2026-08-26
- HighBeckman Coulter DxC 500i Analyzer Modules Recalled for Software Defect
FDA (Devices) · 2026-08-26
- HighMitsubishi Recalls Outlander Models for Rearview Camera Software Defect
NHTSA · 2026-08-25