Randox Laboratories, Ltd.
Complete recall history across all FDA and CPSC categories — 7 total recalls
Randox Laboratories, Ltd. appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.
Device Recalls (7)
FDA medical device enforcement actions by Randox Laboratories, Ltd.
| Date | Product | Reason | Class |
|---|---|---|---|
| Jul 30, 2020 | AM1054 Randox Ammonia (NH3), Enzymatic UV Method For the quantitative in v... | Randox Ammonia reagents are being recalled from the field due to a positive b... | Class II |
| Jul 30, 2020 | AM1015 Randox Ammonia (NH3), Enzymatic UV Method For the quantitative in v... | Randox Ammonia reagents are being recalled from the field due to a positive b... | Class II |
| Jul 10, 2020 | Pancreatic Amylase AY3855 batch 480483 Pancreatic Amylase Ethylidene Blocked... | Amylase AY3805 batch 480449 and Pancreatic Amylase AY3855 batch 480483 have f... | Class II |
| Jul 10, 2020 | Amylase AY3805 batch 480449 Amylase Ethylidene Blocked-pNPG7 Reagent | Amylase AY3805 batch 480449 and Pancreatic Amylase AY3855 batch 480483 have f... | Class II |
| Jun 26, 2020 | Randox Lipase Assay: Lipase Colorimetric Reagent - Product Usage: A Lipase te... | Randox have confirmed imprecision of quality control and patient samples when... | Class II |
| Jun 26, 2020 | Randox Lipase Assay: Lipase Colorimetric R1 Buffer - Product Usage: A Lipase ... | Randox have confirmed imprecision of quality control and patient samples when... | Class II |
| Jun 26, 2020 | Randox Lipase Assay: Lipase Colorimetric R2 Substrate - Product Usage: A Lipa... | Randox have confirmed imprecision of quality control and patient samples when... | Class II |
Frequently Asked Questions
A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.
Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.
The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.
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