FDA recall record · openFDA

Randox Laboratories Ltd.

24 FDA recalls on record (2023–2024) — 24 device. 24 still ongoing.

Class I (most serious)

Class II

Class III

ongoing

How to read this. A recall count is not a quality verdict — large manufacturers recall more simply by volume, and a voluntary recall is the safety system working as intended. The signal to weight is the Class I count (the FDA's most-serious tier — reasonable probability of serious harm or death) and whether recalls are still ongoing. Most recalls are Class II/III. "Ongoing" reflects openFDA's last-published status — device recalls often stay marked ongoing long after they're resolved in practice; confirm current status at the FDA.

Most common reasons

RX Parameter rerun settings (Sample Volume Low/High), and Dilutions used for Auto reruns, not meeting sample re-run con 5

Carryover from the Direct LDL-cholesterol assay on the Rx instruments may result in a negative bias, up to -11%, in qual 1

As part of the firm's ongoing quality monitoring (see internal complaint # OCC72574), Randox Laboratories have restanda 1

Foam gasket on the Evidence MultiSTAT chip heater assembly may not perform as expected. Foam that is not functioning as 1

Delay in reporting results due to Quality Controls running high outside of range. Target value and range for ACTH in Im 1

Recalls

Microalbumin Calibrator Series (mALB CAL)-IVD used to calibrate the Microalbumin Assay Catalog Number: MA1567 Class II 2024-01-31 Microalbumin Calibrator Series (mALB CAL)-IVD to calibrate the Microalbumin Assay Catalog Number: MA2426 Class II 2024-01-31 Clinical Chemistry Calibration Serum (Catalog number Cal2351) that is 20x5ml lyophilized human based serum covering 38 c Class II 2024-03-05 Cystatin C Calibrator - In vitro diagnostic (IVD) use in the calibration of the Randox Cystatin C assay on automated ana Class II 2024-02-14 Liquid Protein Calibrators. C3 and Haptoglobin liquid protein calibrators used with Randox IgA, IgG, and IgM assays that Class II 2024-03-01 RX Series CYSC- Cystatin C Reagent -Intended for in vitro diagnostic (IVD) use as Randox Cystatin C assay on automated a Class II 2024-06-07 Randox RX Series Urea Enzymatic Kinetic Assay Ref. Numbers: (1) UR3825 (2) UR3873 (3) UR8334 (4) UR8070 (Modena Class II 2023-06-13 Randox Liquid Protein Calibrators-SP CAL-(LIQ)-In vitro diagnostic product used for the calibration of ASO, Complement C Class II 2023-07-19 RX Modena-IVD Clinical Chemistry Analyser Catalog Number: RX9000 Class II 2023-09-06 RX Series Copper (Cu) Assay Ref. Number CU2340 Class II 2023-11-29 RX Monaco-IVD Clinical Chemistry Analyser Catalog Number: RX5000 Class II 2023-09-06 Calibration Serum Level 3 - IVD For use as a Calibrator in clinical chemistry assays Catalog Number: CAL2351 Class II 2023-11-20 RX Imola-IVD Clinical Chemistry Analyzer Catalog Number: RX4900. RX4900R (refurbished) Class II 2023-09-06 Calibration Serum Level 3 CAL2351 Class II 2023-11-20 RX Daytona Plus (with ISE)-IVD Clinical Chemistry Analyser Catalog Number: RX4040 Class II 2023-09-06 Randox Liquid Urine Control Level 2- intended for in vitro diagnostic use, in the quality control of Amylase, Calcium, C Class II 2023-06-21 Calibration Serum Level 3. CAL 3, REF CAL2351. Human Assayed Multi-Sera Level 2 (HN1530) Human Assayed Multi-Sera Level Class II 2023-11-13 RANDOX Total Bilirubin. Class II 2023-10-11 RX Daytona Plus (without ISE)- IVD Clinical Chemistry Analyser (1) RX4041, (2) RX4041R (refurbished) Class II 2023-09-06 Liquid Assayed Chemistry Control Premium Plus Level 3, Catalog Number LAE4215 Class II 2023-08-03 Evidence MultiSTAT with software v 3.7-Analyzer intended for the qualitative determination of parent drug molecule and Class III 2024-04-05 Immunoassay Premium Level 3-In vitro diagnostic use, as assayed quality control material to monitor the accuracy and rep Class III 2023-05-04 Immunoassay Premium Control Tri Level-In vitro diagnostic use, as assayed quality control material to monitor the accura Class III 2023-05-04 SEROLOGY ToRCH lgM 2022 POSITIVE CONTROLI Intended for use with in vitro assays for determination of IgM antibodies to C Class III 2023-11-06

RECORDED — these are the FDA's published recall enforcement records (openFDA). Recalls are listed under the exact firm name as filed; a large manufacturer may also file under name variants, so this may not be the company's complete cross-variant record — confirm at the FDA recall database. This page informs and routes; it is not medical advice or a verdict on the company.

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