Randox Laboratories Ltd.
Complete recall history across all FDA and CPSC categories — 72 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 (72)
FDA medical device enforcement actions by Randox Laboratories Ltd.. Showing most recent 50.
| Date | Product | Reason | Class |
|---|---|---|---|
| Jun 7, 2024 | RX Series CYSC- Cystatin C Reagent -Intended for in vitro diagnostic (IVD) us... | Cystatin C Reagent marketed without a 510 (k) | Class II |
| Apr 5, 2024 | Evidence MultiSTAT with software v 3.7-Analyzer intended for the qualitative ... | Foam gasket on the Evidence MultiSTAT chip heater assembly may not perform as... | Class III |
| Mar 5, 2024 | Clinical Chemistry Calibration Serum (Catalog number Cal2351) that is 20x5ml ... | Randox Laboratories has identified that Inorganic Phosphate in Calibration Se... | Class II |
| Mar 1, 2024 | Liquid Protein Calibrators. C3 and Haptoglobin liquid protein calibrators use... | The firm has realigned C3 and Haptoglobin in Liquid Protein Calibrators, IT26... | Class II |
| Feb 14, 2024 | Cystatin C Calibrator - In vitro diagnostic (IVD) use in the calibration of t... | Cystatin C Calibrator Series CVS 2699, is running with a negative bias compar... | Class II |
| Jan 31, 2024 | Microalbumin Calibrator Series (mALB CAL)-IVD to calibrate the Microalbumin A... | Microalbumin Calibrator Series, MA1567 & MA2426, is running with a negative b... | Class II |
| Jan 31, 2024 | Microalbumin Calibrator Series (mALB CAL)-IVD used to calibrate the Microalbu... | Microalbumin Calibrator Series, MA1567 & MA2426, is running with a negative b... | Class II |
| Nov 29, 2023 | RX Series Copper (Cu) Assay Ref. Number CU2340 | Randox Laboratories have released an update to the Carryover Avoidance Techni... | Class II |
| Nov 20, 2023 | Calibration Serum Level 3 CAL2351 | CK Total in Calibration Serum Level 3, CAL2351, is running with a positive bi... | Class II |
| Nov 20, 2023 | Calibration Serum Level 3 - IVD For use as a Calibrator in clinical chemistry... | Target for Alkaline Phosphatase (ALP) for the AMP optimized to IFCC 37¿C met... | Class II |
| Nov 13, 2023 | Calibration Serum Level 3. CAL 3, REF CAL2351. Human Assayed Multi-Sera Level... | There have been transcription errors on the Instructions For Use (IFU) of the... | Class II |
| Nov 6, 2023 | SEROLOGY ToRCH lgM 2022 POSITIVE CONTROLI Intended for use with in vitro assa... | A decrease in the reactivity of HSV Type 1/2 lgM in the Serology ToRCH lgM Po... | Class III |
| Oct 11, 2023 | RANDOX Total Bilirubin. | Randox has had reports of elevated patient results using Plasma (lithium hepa... | Class II |
| Sep 6, 2023 | RX Daytona Plus (without ISE)- IVD Clinical Chemistry Analyser (1) RX4041, (... | RX Parameter rerun settings (Sample Volume Low/High), and Dilutions used for ... | Class II |
| Sep 6, 2023 | RX Daytona Plus (with ISE)-IVD Clinical Chemistry Analyser Catalog Number: R... | RX Parameter rerun settings (Sample Volume Low/High), and Dilutions used for ... | Class II |
| Sep 6, 2023 | RX Imola-IVD Clinical Chemistry Analyzer Catalog Number: RX4900. RX4900R (re... | RX Parameter rerun settings (Sample Volume Low/High), and Dilutions used for ... | Class II |
| Sep 6, 2023 | RX Monaco-IVD Clinical Chemistry Analyser Catalog Number: RX5000 | RX Parameter rerun settings (Sample Volume Low/High), and Dilutions used for ... | Class II |
| Sep 6, 2023 | RX Modena-IVD Clinical Chemistry Analyser Catalog Number: RX9000 | RX Parameter rerun settings (Sample Volume Low/High), and Dilutions used for ... | Class II |
| Aug 3, 2023 | Liquid Assayed Chemistry Control Premium Plus Level 3, Catalog Number LAE4215 | there has been a transcription error in the Instructions for Use (IFU) for th... | Class II |
| Jul 19, 2023 | Randox Liquid Protein Calibrators-SP CAL-(LIQ)-In vitro diagnostic product us... | As part of the firm's ongoing quality monitoring (see internal complaint # O... | Class II |
| Jun 21, 2023 | Randox Liquid Urine Control Level 2- intended for in vitro diagnostic use, in... | (1) There is vial to vial variation resulting in some vials recovering positi... | Class II |
| Jun 13, 2023 | Randox RX Series Urea Enzymatic Kinetic Assay Ref. Numbers: (1) UR3825 (... | Carryover from the Direct LDL-cholesterol assay on the Rx instruments may res... | Class II |
| May 4, 2023 | Immunoassay Premium Control Tri Level-In vitro diagnostic use, as assayed qua... | Delay in reporting results due to Quality Controls running high outside of ra... | Class III |
| May 4, 2023 | Immunoassay Premium Level 3-In vitro diagnostic use, as assayed quality contr... | Delay in reporting results due to Quality Controls running high outside of ra... | Class III |
| Nov 22, 2022 | Liquid Assayed Specific Protein Control Level 3- In vitro diagnostic use, in ... | Concentration of Rheumatoid Factor has decreased in Specific Protein Control ... | Class II |
| Nov 22, 2022 | Liquid Assayed Specific Protein- In vitro diagnostic use, in the quality cont... | Concentration of Rheumatoid Factor has decreased in Specific Protein Control ... | Class II |
| Nov 22, 2022 | Liquid Assayed Specific Protein Control Level 2- In vitro diagnostic use, in... | Concentration of Rheumatoid Factor has decreased in Specific Protein Control ... | Class II |
| Nov 1, 2022 | IgA Immunoturbidimetric Assay- In vitro determination of IgA and IgM in serum... | Update to the carryover avoidance technical bulletin to detail that IgA and I... | Class II |
| Nov 1, 2022 | IgM Immunoturbidimetric Assay-In vitro determination of IgA and IgM in serum ... | Update to the carryover avoidance technical bulletin to detail that IgA and I... | Class II |
| Aug 1, 2022 | The Randox Serology I Positive Control contains the following analytes in hum... | ***Update** :HBsAg analyte is also Non-Reactive on the Ortho Vitros analyser ... | Class II |
| Jun 22, 2022 | Randox Cholesterol- For the quantitative in vitro determination of Cholester... | Product fails to meet the performance claims quoted on the kit insert: Manual... | Class II |
| Jun 9, 2022 | Soluble Transferrin Receptors Calibrator Series (STFR CAL), Catalog Number TF... | A customer reported a problem with the reagent and calibrator. Randox Laborat... | Class III |
| Jun 9, 2022 | Soluble Transferrin Receptors (STFR), Catalog Number TF10159 (Research Use On... | A customer reported a problem with the reagent and calibrator. Randox Laborat... | Class III |
| Mar 25, 2022 | CK MB Calibrator, Catalogue Number CK2393 | Randox have realigned CK-MB Calibrator, CK2393, lot number 4410CK. Calibratin... | Class III |
| Nov 1, 2021 | RANDOX CHOL-cholesterol (total) test system intended to measure cholesterol i... | When calibrating using the standard provided in the kit, the change in absorb... | Class II |
| May 10, 2021 | NEFA CAL (Non-Esterified Fatty Acids)- IVD Standard for measurement of NEFA ... | Standard packed within NEFA kit has been assigned incorrectly. Calibrating w... | Class II |
| Apr 28, 2021 | Randox RX Imola Analyser with ISE, Catalog Numbers RX4900, RX4900R | An issue was identified where the software froze during processing of command... | Class II |
| Mar 29, 2021 | Calibration Serum Level 3 (CAL 3) - multi-analyte mixture calibrator. Catal... | Randox can confirm a positive bias for Total Bilirubin and Direct Bilirubin o... | Class II |
| Nov 13, 2020 | Randox Rx Series Mg - Product Usage: For the quantitative in vitro determinat... | Failing to meet the linearity performance claims quoted on the kit inserts-T... | Class II |
| Nov 13, 2020 | Randox Mg R1 - Product Usage: For the quantitative in vitro determination of ... | Failing to meet the linearity performance claims quoted on the kit inserts-T... | Class II |
| Aug 11, 2020 | Lactate Dehydrogenase L-P, (LDH) (NAO), Catalog Number LD3842 - Product Usage... | An update to the carryover avoidance technical bulletin to introduce addition... | Class II |
| Aug 11, 2020 | Lactate Dehydrognease P-L, (UV), Catalog Number LD3818 - Product Usage: devic... | An update to the carryover avoidance technical bulletin to introduce addition... | Class II |
| Feb 18, 2020 | Chemistry QC Premium Plus, Cat. No. LAL4213, GTIN 05055273209006 - Product Us... | The control target and range value for Sodium using the ISE indirect method h... | Class II |
| Dec 13, 2019 | Liquid Clinical Chemistry Control, Catalogue Number: LAE4217, Size: 12 x 5 ml | A transcription error has occurred for the Randox Lipase colorimetric value i... | Class III |
| Aug 9, 2019 | Rheumatoid Factor Standard (RF CAL) Catalogue Number: RF2301 GTIN: 05055273... | The assigned value for Rheumatoid Factor over recovers against the reference ... | Class II |
| Aug 9, 2019 | Liquid Protein Calibrators (SP CAL (LIQ)) Catalogue Number: IT2691 GTIN: 05... | The assigned value for Rheumatoid Factor over recovers against the reference ... | Class II |
| Jul 25, 2019 | Randox Urinalysis Control Level 2 (IVD) Ref: UC5034 - Product Usage: Prod... | Analyte range for Leukocytes for use with the Siemens Multistix method is inc... | Class III |
| Jul 12, 2019 | This is an in vitro diagnostic product intended for use as a calibration seru... | Randox Laboratories realigned RX Analyser Series calibration targets by 10% f... | Class III |
| Apr 3, 2019 | G-6-PDH Deficient Control (G-6-PDH CONTROL D), Catalogue Number PD2617 Pro... | The target values and ranges in these lots are incorrect. | Class II |
| Apr 3, 2019 | G-6-PDH Normal Control (G-6-PDH CONTROL N), Catalogue Number PD2618 Produc... | The target values and ranges in these lots are incorrect. | 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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