Diagnostics makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in United KingdomLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 7 spellings of its name, each linked to the record.
As of Nov 14, 2026, FDA's public records list Randox Laboratories with 133 510(k) clearances, 98 device recalls and 1 warning letter. The most recent is a 510(k) clearance dated Jan 23, 2026: Evidence MultiSTAT DOA Urine MultiPlex.
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Jan 23, 2026 | Evidence MultiSTAT DOA Urine MultiPlexK250741 · DJG | 510(k) clearances |
| May 22, 2025 | ConcizuTrace™ ELISADEN240035 · SES | 510(k) clearances |
| Dec 6, 2024 | Warning letter: Cleaning validation, CAPA, Complaint handlingCDRH | Warning letters |
| Oct 5, 2023 | Evidence MultiSTAT DOA Urine MultiPlex, Evidence MultiSTATK220451 · DJG | 510(k) clearances |
| Oct 5, 2023 | Evidence MultiSTAT DOA Urine MultiPlexK221550 · DJG | 510(k) clearances |
| Sep 8, 2023 | ISE ElectrodesK230890 · CEM | 510(k) clearances |
| Feb 1, 2023 | CRP Immunoturbidimetric reagent. Intended for the quantitative in vitro determination of CRP concentration in serum Catalogue number: CP382Class II · The Antibody (R2 reagent) is showing a positive bias compared to previous batches on patient samples. Quality Controls d | Device recalls |
| Oct 23, 2018 | Randox Calcium (Ca)K182042 · CJY | 510(k) clearances |
| May 4, 2018 | RX Imola (RX4900) For Professional Use for the quantitative in vitro determination of various clinical chemistry tests.Class II · Abnormal premature termination of the software could affect the use of the analyser when running patient samples. The im | Device recalls |
| Aug 11, 2017 | Immunoassay Premium Controls (3x4x5mL and 12x5mL packages)Class III · The ACTH in Immunoassay Premium and Premium Plus quality control does not meet the quoted reconstituted stability claim | Device recalls |
| Aug 11, 2017 | Immunoassay Premium Plus Controls (3x4x5mL and 12x5mL packages)Class III · The ACTH in Immunoassay Premium and Premium Plus quality control does not meet the quoted reconstituted stability claim | Device recalls |
| Apr 28, 2017 | Randox RX Daytona Plus Magnesium (MG)K162200 · JGJ | 510(k) clearances |
| Apr 27, 2017 | Liquid Urine Control Level 3 For Professional Use in the quality control monitoring of In-Vitro Diagnostic Urinary Clinical Assays on a rClass III · According to Randox Laboratories an investigation indicates a labelling error for 2 of the test methods listed for quant | Device recalls |
| Apr 21, 2017 | Randox RX Daytona Plus Alkaline Phosphatase (ALP)K162275 · CJE | 510(k) clearances |
| Sep 16, 2016 | The Randox Liquid Cardiac Controls Level 1, Level 2, and Level 3 are liquid controls containing BNP, CK MB Mass, Digoxin, D-Dimer, HomocysteClass II · An internal real-time stability monitoring program revealed decreased recovery of myoglobin (-20% bias) for Randox Immun | Device recalls |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
