Randox Laboratories Recalls Amylase Reagents Due to Performance Failures
Randox Laboratories is recalling specific batches of Amylase reagents because they failed to meet performance claims prior to their September 2020 expiry date.
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 indicates a failure to meet performance claims rather than a direct safety hazard like contamination or injury, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Randox Laboratories, Ltd. is recalling Amylase AY3805 batch 480449 and Pancreatic Amylase AY3855 batch 480483. The recall was initiated because these products failed to meet the quoted performance claims prior to their expiry date of September 28, 2020.
The affected Amylase AY3805 batch 480449 was distributed in New Mexico, Massachusetts, and West Virginia, as well as to numerous foreign countries including Bolivia, Bosnia and Herzegovina, Brazil, and the United Kingdom. The source text does not specify the distribution locations for the Pancreatic Amylase AY3855 batch 480483.
Healthcare facilities and laboratories should stop using the affected batches and contact Randox Laboratories for further instructions. Consumers are not directly affected as these are professional laboratory reagents.
The recalled product
- Product
- Amylase AY3805 batch 480449 Amylase Ethylidene Blocked-pNPG7 Reagent
- Manufacturer
- RANDOX LABORATORIES, LTD.
- Hazard
- Affected units
- 1,497
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)
- AY3805 GTIN 05055273200607
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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