Randox Blood Gas Control Level 2 Recalled for pH Range Error
Randox Laboratories is recalling Blood Gas Control Level 2 kits due to an error in the assignment of the control range pH.
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: The recall is classified as FDA Class II, and the hazard is a labeling/assignment error in a quality control product without reported injuries or illnesses, fitting the criteria for a moderate severity score.
Plain-English summary
Randox Laboratories Ltd. is recalling Randox Blood Gas Control Level 2 (Model BG5002) kits. This product is an in-vitro diagnostic quality control material intended for the quality control of Blood Gas analysis. The recall is being conducted because of an error in the assignment of the control range pH.
The affected product is identified by Lot Code 184BG and GTIN 05055273227116. The distribution pattern for this recall is limited to the state of West Virginia (WV). The product is intended for use in quality control for analytes including Calcium, Chloride, Glucose, Lactate, PCO2, pH, pO2, Potassium, Sodium, and Total CO2.
Consumers and healthcare facilities should stop using the affected product and contact Randox Laboratories Ltd. for further instructions or a replacement.
The recalled product
- Product
- Randox Blood Gas Control Level 2 -Model BG5002. In-vitro Diagnostic Quality control of Blood Gas analysis This product is intended for in vitro diagnostic use, in the quality control of Blood Gas analysis. Target values and ranges are supplied for the following analytes…
- Manufacturer
- Randox Laboratories Ltd.
- Hazard
- Affected units
- 1
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)
- Lot Code: 184BG GTIN: 05055273227116
Distribution
Distributed in 1 state:
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