Randox Laboratories, Limited
Complete recall history across all FDA and CPSC categories — 13 total recalls
Randox Laboratories, Limited 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 (13)
FDA medical device enforcement actions by Randox Laboratories, Limited
| Date | Product | Reason | Class |
|---|---|---|---|
| Dec 20, 2024 | Randox Lipoprotein (a) - In vitro diagnostic (IVD) use as Randox Lipoprotein... | Lipoprotein (a) on Roche Cobas c501 with nmol/l claims does not have a 510(k)... | Class II |
| Dec 20, 2024 | Randox Lipoprotein (a) - In vitro diagnostic (IVD) use as Randox Lipoprotein ... | Lipoprotein (a) on Roche Cobas c501 with nmol/l claims does not have a 510(k)... | Class II |
| Dec 19, 2019 | RX Daytona Plus (with ISE/without ISE); Models Nos. RX4040 (w/ISE) and RX4041... | Software version UI2550642107 for the RX Daytona + instrument released to cor... | Class II |
| Oct 4, 2019 | Randox Liquid Cardiac Controls Catalogue Number CQ5052. | Removal of claims for N-proBNP in the Liquid Cardiac Control catalogue number... | Class II |
| Oct 4, 2019 | Randox Liquid Cardiac Controls Catalogue Number CQ5051 | Removal of claims for N-proBNP in the Liquid Cardiac Control model numbers CQ... | Class II |
| Oct 4, 2019 | Randox Liquid Cardiac Controls Catalogue Numbers CQ5053. | Removal of claims for N-proBNP in the Liquid Cardiac Control catalogue number... | Class II |
| Sep 23, 2019 | RANDOX NEFA (Non-Esterified Fatty Acids) FA115 Lot 485343, GTIN: 5055273203066. | Non-Esterified Fatty Acids (NEFA) FA115 batch 485343 is not meeting the perfo... | Class III |
| Jun 24, 2019 | RX Imola, Model Nos. RX4900 | There was a report of a malfunction with the sensor which resulted in an incr... | Class II |
| Jun 24, 2019 | RX Daytona, Model Nos. RX4040 and RX4041 | There was a report of a malfunction with the sensor which resulted in an incr... | Class II |
| Jun 11, 2019 | Human Assayed Multi-Sera Level 2, Model NO. HN1530 Product Usage: This pr... | The RX Series control target and range value for ALT (Tris buffer without P5P... | Class II |
| Jun 10, 2019 | Assayed Bovine Multi-Sera Level 1, Model No. AL1027 | The firm is re-assigning the Mean of all Instruments target and range for Bil... | Class III |
| Aug 8, 2017 | Liquid Cardiac Control CQ5053 | Randox has confirmed that Troponin T and Troponin I in Liquid Cardiac quality... | Class II |
| Apr 14, 2016 | Magnesium on RX Imola analyser IVD | According to the firm, Carry over was observed when the amylase or pancreatic... | 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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