Medical device manufacturer
Randox Laboratories, Limited
Randox Laboratories, Limited holds 133 FDA 510(k) clearances across 76 product codes. Median elapsed review time is 124 days. openFDA lists 98 recall records naming the company. FDA publishes it under 11 different spellings, all counted here as one company.
Updated · ingest status · JSON
- 510(k) clearances
- 133
- Product codes
- 76
- Median review
- 124 days
- Recall records
- 98
How does FDA spell Randox Laboratories, Limited?
FDA publishes this company under 11 different spellings across its datasets. Every figure on this page counts all of them as one company, which is why the totals here are higher than a search for any single spelling would give you.
| As FDA published it | Dataset | Matched by |
|---|---|---|
| RANDOX LABORATORIES LIMITED | device/registrationlisting | normalised |
| RANDOX LABORATORIES, LTD. | device/recall | normalised |
| RANDOX LABORATORIES, LTD. | device/enforcement | normalised |
| Randox Laboratories | device/enforcement | normalised |
| Randox Laboratories | device/recall | normalised |
| Randox Laboratories Limited | device/510k | normalised |
| Randox Laboratories Ltd. | device/enforcement | normalised |
| Randox Laboratories Ltd. | device/recall | normalised |
Showing 8 of 11.
Merges are measured against a hand-labelled sample and held above 98% precision. Pairs the matcher is unsure of are queued for a person rather than merged, because two genuinely different firms with similar names is the error that would corrupt every count on this page.
Which product codes does Randox Laboratories, Limited file in?
76 product codes, ranked by how much they file in each.
| Code | Device | Clearances | Median review | Latest |
|---|---|---|---|---|
| JJY | Multi-Analyte Controls, All Kinds (Assayed) | 15 | 120 days | |
| DJG | Enzyme Immunoassay, Opiates | 5 | 318 days | |
| JIX | Calibrator, Multi-Analyte Mixture | 5 | 78 days | |
| JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 5 | 28 days | |
| CGS | Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes | 3 | 281 days | |
| DCK | C-Reactive Protein, Antigen, Antiserum, And Control | 3 | 84 days | |
| DJR | Enzyme Immunoassay, Methadone | 3 | 469 days | |
| JIS | Calibrator, Primary | 3 | 85 days | |
| LBS | Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl | 3 | 42 days | |
| CDT | Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides | 2 | 132 days | |
| CEM | Electrode, Ion Specific, Potassium | 2 | 161 days | |
| CGA | Glucose Oxidase, Glucose | 2 | 141 days | |
| CHH | Enzymatic Esterase--Oxidase, Cholesterol | 2 | 200 days | |
| CJE | Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes | 2 | 141 days | |
| CJY | Azo Dye, Calcium | 2 | 54 days | |
| DHR | System, Test, Rheumatoid Factor | 2 | 89 days | |
| DIO | Enzyme Immunoassay, Cocaine And Cocaine Metabolites | 2 | 139 days | |
| DIS | Enzyme Immunoassay, Barbiturate | 2 | 189 days | |
| DKB | Calibrators, Drug Mixture | 2 | 51 days | |
| DKZ | Enzyme Immunoassay, Amphetamine | 2 | 90 days | |
| JFM | Enzymatic Method, Bilirubin | 2 | 162 days | |
| JGJ | Photometric Method, Magnesium | 2 | 64 days | |
| JHN | Turbidimetric Method, Lipoproteins | 2 | 227 days | |
| JJW | Urinalysis Controls (Assayed And Unassayed) | 2 | 81 days | |
| JXM | Enzyme Immunoassay, Benzodiazepine | 2 | 111 days |
Showing the 25 they file in most, of 76.
Median review is elapsed calendar days between date received and decision date, as published by FDA. It is not FDA review days — the two differ whenever the agency stops the clock for an additional information request.
Source: openFDA device/510k · retrieved
Has Randox Laboratories, Limited had a recall?
openFDA lists 98 recall records naming this company across its whole history. A recall record covers one firm's corrective action and may span many device lots.
Z-1017-2025Class IIOpen, ClassifiedDFC
Lipoprotein (a) on Roche Cobas c501 with nmol/l claims does not have a 510(k) or PMA.
Z-1018-2025Class IIOpen, ClassifiedDFC
Lipoprotein (a) on Roche Cobas c501 with nmol/l claims does not have a 510(k) or PMA.
Z-2425-2024Class IIOpen, ClassifiedNDY
Cystatin C Reagent marketed without a 510 (k)
Z-1786-2024Class IIIOpen, ClassifiedJJE
Foam gasket on the Evidence MultiSTAT chip heater assembly may not perform as expected. Foam that is not functioning as expected may cause light to leak into the Charged Coupled Device (CCD) Camera during imaging. This will affect the testing and may delay in reporting results.
Z-1759-2024Class IIOpen, ClassifiedJIX
Randox Laboratories has identified that Inorganic Phosphate in Calibration Serum Level 3, CAL2351 & CAL10388, is running with a negative bias on RX Series instruments compared to other methods.
Showing the 5 most recently initiated of 98.
Recall class comes from openFDA's enforcement endpoint, which does not carry every recall — where it is missing, none is shown rather than guessed. Recall class I is the most serious kind of recall; device class I is the least risky kind of device, and the two are never mixed here.
Source: openFDA device/recall · retrieved
What has Randox Laboratories, Limited cleared recently?
| 510(k) | Device | Code | Decision | Elapsed days |
|---|---|---|---|---|
| K250741 | Evidence MultiSTAT DOA Urine MultiPlex | DJG | 318 | |
| K221550 | Evidence MultiSTAT DOA Urine MultiPlex | DJG | 492 | |
| K220451 | Evidence MultiSTAT DOA Urine MultiPlex, Evidence MultiSTAT | DJG | 595 | |
| K230890 | ISE Electrodes | CEM | 161 | |
| K182042 | Randox Calcium (Ca) | CJY | 85 | |
| K162200 | Randox RX Daytona Plus Magnesium (MG) | JGJ | 266 | |
| K162275 | Randox RX Daytona Plus Alkaline Phosphatase (ALP) | CJE | 252 | |
| K161691 | Direct LDL Cholesterol (LDL) | MRR | 273 | |
| K152085 | Liquid CO2-2 (LCO2-2) | KHS | 212 | |
| K152343 | Direct Bilirubin | JFM | 181 |
Source: openFDA device/510k · retrieved
Where is Randox Laboratories, Limited registered?
FDA lists 2 registered establishments for this company in US.
Registration means the firm has told FDA it makes or distributes devices from that site. It is not a clearance, an approval or an endorsement.
Watch what Randox Laboratories, Limited files next
Get an email when this company clears a new device, or when anything is recalled in a product code you follow.
Data on this page comes from FDA's public openFDA API and is US public domain (CC0). DeviceSignal is an independent commercial service and is not affiliated with the U.S. Food and Drug Administration. Information only, not regulatory advice. Verify anything you rely on against open.fda.gov.