Randox Calcium Reagent Recall for Potential Carryover Errors
Randox Laboratories is recalling Calcium reagents due to a technical bulletin update regarding reagent carryover, which may cause inaccurate test results.
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 an FDA Class II recall involving a technical update to avoid reagent carryover, which could lead to inaccurate test results but does not involve reported injuries or hospitalizations.
Plain-English summary
Randox Laboratories Ltd. is recalling 225 kits of Randox CALCIUM (Ca) Colorimetric Method RX Series (Cat. No. CA 3871, R1. Arsenazo Reagent 9 x 51ml, GTIN: 05055273200904). The recall involves all lot codes and affects products distributed in West Virginia and Puerto Rico.
The recall is an update to a carryover avoidance technical bulletin to introduce additional steps for reagent carryover avoidance with the Calcium assay on RX instruments. Carryover to the Calcium reagent results may result in falsely elevated or decreased results to both patient and QC samples.
No specific instructions for consumers are provided in the source text, as this is a medical device recall affecting laboratory testing equipment.
The recalled product
- Product
- Randox CALCIUM (Ca) Colorimetric Method RX Series Cat. No. CA 3871, R1. Arsenazo Reagent 9 x 51ml GTIN: 05055273200904
- Manufacturer
- Randox Laboratories Ltd.
- Hazard
- Affected units
- 225
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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