Randox NEFA FA115 Recalled for Performance Failure
Randox Laboratories is recalling NEFA FA115 Lot 485343 because it is not meeting performance claims and should not be used for testing.
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 III, which indicates the product is unlikely to cause adverse health consequences. The issue is a performance failure rather than a direct safety hazard like contamination or injury.
Plain-English summary
Randox Laboratories, Limited is recalling the RANDOX NEFA (Non-Esterified Fatty Acids) FA115 product, specifically Lot 485343. The recall is due to the product not meeting its performance claims. The agency has determined that the product should not be used in any further testing.
The recall involves 212 units, distributed to 19 locations in the United States and 193 locations internationally. The product is identified by Catalogue number FA115, GTIN 05055273203066, and Batch/Lot 485343, with an expiration date of March 2019.
Users of this product should stop using it immediately and contact Randox Laboratories for instructions on how to return or dispose of the affected units.
The recalled product
- Product
- RANDOX NEFA (Non-Esterified Fatty Acids) FA115 Lot 485343, GTIN: 5055273203066.
- Manufacturer
- Randox Laboratories, Limited
- Hazard
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)
- Catalogue number: FA115 GTIN: 05055273203066 Batch/Lot: 485343 Exp: Mar 2019
Distribution
Distribution scope not specified by the agency.
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