Randox HbA1c Reagent Recalled for Low Calibration Absorbance
Randox Laboratories is recalling 90 kits of HbA1c reagent (Batch 414553) due to low calibration absorbance that may affect performance.
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, but the source text describes a performance characteristic issue (low calibration absorbance) without reporting any specific injuries, illnesses, or hospitalizations, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Randox Laboratories Ltd. is recalling 90 kits of Rx series HbA1c reagent, Catalog Number HA3830, Batch 414553. The product is an in vitro diagnostic (IVD) reagent used for the quantitative determination of Haemoglobin A1c concentration in whole blood on RX series instruments, including the RX Daytona and RX Imola analysers.
The recall was initiated because Randox confirmed low calibration absorbance with the specific batch. The company stated that the reagent may not continue to meet its specific performance characteristics throughout the shelf life of the product.
The affected product was distributed in Puerto Rico and internationally in Portugal, Italy, Turkey, Slovakia, Russia, Thailand, and Vietnam. The lot has an expiry date of January 28, 2019. Users of this product should stop using the affected reagent and contact Randox Laboratories for further instructions.
The recalled product
- Product
- Rx series HbA1c REF/Catalog Number HA3830, GTIN 05055273203561, IVD; -- RANDOX LABORATORIES LTD. , This product is suitable for use on RX series instruments which includes the RX Daytona and RX Imola analysers. Packaging Format: HbA1c R1: Antibody Reagent - 3 x 14 ml
- Manufacturer
- Randox Laboratories Ltd.
- Hazard
- Affected units
- 90
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 (2)
- Lot/Batch 414553
- expiry 28th Jan 2019
Distribution
Distributed in 1 state:
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