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

0Oct '24 0 0 2Jan '25 0 0 0Apr 0 0 0Jul 0 0 0Oct 0 0 0Jan '26 0 0 0Apr 0 0 0Jul 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	Potency & Assay	Nationwide
29 Jan 2025Device	CLASS II	Randox Lipoprotein (a) - In vitro diagnostic recalled	Randox Laboratories	Potency & Assay	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	Potency & Assay	Nationwide
29 Jan 2025Device	CLASS II	Randox Lipoprotein (a) - In vitro diagnostic recalled	Randox Laboratories	Potency & Assay	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	Lead & Heavy Metals	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.