Randox Magnesium IVD Reagent Recalled for Carryover Interference
Randox Laboratories is recalling 15 units of Magnesium IVD reagents for the RX Imola analyser due to carryover interference from amylase tests.
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 involves potential test inaccuracy due to carryover, which is a moderate risk to patient care but does not involve immediate physical injury or death.
Plain-English summary
Randox Laboratories, Limited is recalling 15 units of Magnesium on RX Imola analyser IVD reagents. The recall was initiated because carryover was observed when the amylase or pancreatic amylase test is run directly before or after the Magnesium assay. This interference could affect the accuracy of the test results.
The affected products were distributed nationwide to US consignees. The specific reagent code is MG3880 and the analyser code is RX4900. The firm has corrected the Instructions for Use (IFU) for the Magnesium assay and contacted all RX Imola customers in the USA with the updated instructions. An update to the running order and an acid wash are recommended when setting up the magnesium assay.
The recalled product
- Product
- Magnesium on RX Imola analyser IVD
- Manufacturer
- Randox Laboratories, Limited
- Affected units
- 15
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)
- reagent: MG3880 analyser: RX4900
Distribution
Distributed nationwide across the United States.
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