Randox Calcium Reagent Recall for Potential Carryover Errors
Randox Laboratories is recalling Calcium reagents due to a technical bulletin update regarding reagent carryover. This issue may cause falsely elevated or decreased results in patient and QC samples.
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. The hazard involves potential diagnostic errors (falsely elevated or decreased results) rather than direct physical injury or death, and no illnesses or injuries are reported in the source text.
Plain-English summary
Randox Laboratories Ltd. is recalling the Randox CALCIUM (Ca) COLORIMETRIC METHOD RX DAYTONA PLUS Arsenazo Reagent (Cat. No. CA 8309 R1). The recall is an update to a carryover avoidance technical bulletin that introduces additional steps to prevent reagent carryover with the Calcium assay on RX instruments.
The identified issue is that carryover to the Calcium reagent results may result in falsely elevated or decreased results for both patient and quality control (QC) samples. The source text does not report any specific illnesses, injuries, or deaths associated with this recall.
The recall affects all lot codes of the product. Distribution is listed as WV and PR. Consumers and healthcare facilities should follow the updated technical bulletin steps to avoid reagent carryover.
The recalled product
- Product
- Randox CALCIUM (Ca) COLORIMETRIC METHOD RX DAYTONA PLUS Cat. No. CA 8309 R1, Arsenazo Reagent 4 x 20 ml GTIN: 05055273208368
- Manufacturer
- Randox Laboratories Ltd.
- 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)
- All lot codes
Distribution
Part of a larger recall action
This product is one of 2 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.
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