Randox Laboratories recalls

Randox Laboratories has 98 recalls on record with the FDA and USDA, the earliest in 2016 and the latest reported on 29 Jan 2025. 34 are still ongoing. The most frequent reason is potency & assay.

Total recalls98since 2016

Last 12 months0reported

Class I00% of total

Ongoing34latest 29 Jan 2025

Recalls per month, last 24 months

click a bar for that month

0Nov '24 0 2 0Feb 0 0 0May 0 0 0Aug 0 0 0Nov 0 0 0Feb 0 0 0May 0 0 0Aug 0 0

Severity split

Class I 0 0%Class II 80 82%Class III 18 18%

Why randox laboratories is recalled

Product types

By year

202522%
20241212%
20231616%
202277%
202144%
20201414%
20192526%
20181313%
201711%
201644%

Ongoing randox laboratories recalls

34 active

Reported	Class	Recall	Company	Reason	Where
29 Jan 2025Device	CLASS II	Randox Lipoprotein (a) - In vitro diagnostic recalled	Randox Laboratories	Device Malfunction	Nationwide
29 Jan 2025Device	CLASS II	Randox Lipoprotein (a) - In vitro diagnostic recalled	Randox Laboratories	Device Malfunction	Nationwide
31 Jul 2024Device	CLASS II	RX Series CYSC- Cystatin C Reagent -Intended recalled	Randox Laboratories	Potency & Assay	Nationwide
15 May 2024Device	CLASS II	Clinical Chemistry Calibration Serum recalled by Randox Laboratories	Randox Laboratories	Other	Nationwide
15 May 2024Device	CLASS III	Evidence MultiSTAT recalled by Randox Laboratories	Randox Laboratories	Packaging Defects	Nationwide
24 Apr 2024Device	CLASS II	Microalbumin Calibrator Series recalled by Randox Laboratories	Randox Laboratories	Potency & Assay	Nationwide

All randox laboratories recalls, newest first

98 total

Reported	Class	Recall	Company	Reason	Where
29 Jan 2025Device	CLASS II	Randox Lipoprotein (a) - In vitro diagnostic recalled	Randox Laboratories	Device Malfunction	Nationwide
29 Jan 2025Device	CLASS II	Randox Lipoprotein (a) - In vitro diagnostic recalled	Randox Laboratories	Device Malfunction	Nationwide
31 Jul 2024Device	CLASS II	RX Series CYSC- Cystatin C Reagent -Intended recalled	Randox Laboratories	Potency & Assay	Nationwide
15 May 2024Device	CLASS II	Clinical Chemistry Calibration Serum recalled by Randox Laboratories	Randox Laboratories	Other	Nationwide
15 May 2024Device	CLASS III	Evidence MultiSTAT recalled by Randox Laboratories	Randox Laboratories	Packaging Defects	Nationwide
24 Apr 2024Device	CLASS II	Microalbumin Calibrator Series recalled by Randox Laboratories	Randox Laboratories	Potency & Assay	Nationwide
24 Apr 2024Device	CLASS II	Microalbumin Calibrator Series recalled by Randox Laboratories	Randox Laboratories	Potency & Assay	Nationwide
3 Apr 2024Device	CLASS II	Cystatin C Calibrator - In vitro diagnostic (IVD) use recalled	Randox Laboratories	Potency & Assay	Nationwide
27 Mar 2024Device	CLASS II	Liquid Protein Calibrators recalled by Randox Laboratories	Randox Laboratories	Potency & Assay	7 states
14 Feb 2024Device	CLASS II	RX Series Copper (Cu) Assay recalled by Randox Laboratories	Randox Laboratories	Potency & Assay	Nationwide
24 Jan 2024Device	CLASS II	Calibration Serum Level CAL recalled by Randox Laboratories	Randox Laboratories	Potency & Assay	Nationwide
24 Jan 2024Device	CLASS II	Calibration Serum Level 3 CAL2351 recalled by Randox Laboratories	Randox Laboratories	Other	Nationwide
24 Jan 2024Device	CLASS II	Calibration Serum Level 3 - IVD For use as a Calibrator recalled	Randox Laboratories	Potency & Assay	Nationwide
10 Jan 2024Device	CLASS III	Serology ToRCH lgM 2022 Positive Controli Intended recalled	Randox Laboratories	Potency & Assay	NY, WV
13 Dec 2023Device	CLASS II	Randox Total Bilirubin recalled by Randox Laboratories	Randox Laboratories	Other	Nationwide
8 Nov 2023Device	CLASS II	RX Daytona Plus (without ISE)- IVD Clinical Chemistry recalled	Randox Laboratories	Potency & Assay	Nationwide
8 Nov 2023Device	CLASS II	RX Daytona Plus (with ISE)-IVD Clinical Chemistry Analyser recalled	Randox Laboratories	Potency & Assay	Nationwide
8 Nov 2023Device	CLASS II	RX Imola-IVD Clinical Chemistry Analyzer recalled by Randox Laboratories	Randox Laboratories	Potency & Assay	Nationwide
8 Nov 2023Device	CLASS II	RX Monaco-IVD Clinical Chemistry Analyser recalled	Randox Laboratories	Potency & Assay	Nationwide
8 Nov 2023Device	CLASS II	RX Modena-IVD Clinical Chemistry Analyser recalled	Randox Laboratories	Potency & Assay	Nationwide
27 Sep 2023Device	CLASS II	Liquid Assayed Chemistry Control Premium Plus Level recalled	Randox Laboratories	Potency & Assay	6 states
30 Aug 2023Device	CLASS II	Randox Liquid Urine Control Level 2- intended recalled	Randox Laboratories	Device Malfunction	Nationwide
30 Aug 2023Device	CLASS II	Randox Liquid Protein Calibrators-SP CAL-(LIQ)-In vitro recalled	Randox Laboratories	Potency & Assay	9 states
16 Aug 2023Device	CLASS II	Randox RX Series Urea Enzymatic Kinetic Assay recalled	Randox Laboratories	Potency & Assay	Nationwide
5 Jul 2023Device	CLASS III	Immunoassay Premium Control Tri Level-In vitro diagnostic recalled	Randox Laboratories	Potency & Assay	6 states
5 Jul 2023Device	CLASS III	Immunoassay Premium Level vitro diagnostic use recalled	Randox Laboratories	Potency & Assay	6 states
5 Apr 2023Device	CLASS II	CRP Immunoturbidimetric reagent recalled by Randox Laboratories	Randox Laboratories	Other	OH, PA, WV
11 Jan 2023Device	CLASS II	Liquid Assayed Specific Protein Control Level vitro recalled	Randox Laboratories	Potency & Assay	Nationwide
11 Jan 2023Device	CLASS II	Liquid Assayed Specific Protein- In vitro diagnostic use recalled	Randox Laboratories	Potency & Assay	Nationwide
11 Jan 2023Device	CLASS II	Liquid Assayed Specific Protein Control Level vitro recalled	Randox Laboratories	Potency & Assay	Nationwide

About this list

Records come from FDA enforcement reports and USDA FSIS notices, grouped by normalised name. A company operating under several names may appear more than once.