Randox Pancreatic Amylase Reagents Recalled for Performance Failure
Randox Laboratories is recalling specific batches of Pancreatic 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, which typically indicates a situation where use of the product may cause temporary or medically reversible health consequences. The specific hazard is a failure to meet performance claims, which is a functional defect rather than a direct physical or biological injury risk, aligning with a Moderate severity rating.
Plain-English summary
Randox Laboratories, Ltd. is recalling specific batches of Pancreatic Amylase AY3855 and Amylase AY3805 reagents. The affected products include Pancreatic Amylase AY3855 batch 480483 and Amylase AY3805 batch 480449. The recall involves 105 units of the Pancreatic Amylase AY3855 product.
The recall was initiated because the products failed to meet the quoted performance claims prior to their expiry date of September 28, 2020. This performance failure may affect the accuracy of laboratory test results.
The products were distributed in New Mexico, Massachusetts, and West Virginia, as well as to numerous foreign countries including Bolivia, Brazil, France, India, Italy, and the United Kingdom. Consumers and healthcare facilities should stop using the affected batches and contact Randox Laboratories for further instructions.
The recalled product
- Product
- Pancreatic Amylase AY3855 batch 480483 Pancreatic Amylase Ethylidene Blocked-pNPG7 Reagent
- Manufacturer
- RANDOX LABORATORIES, LTD.
- Hazard
- Affected units
- 105
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)
- AY3855 GTIN 05055273200614
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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