Randox Laboratories Limited
Country not established FDA establishment FEI 3004493545
- Devices
- 8
- Registrations
- FDA
- FDA recalls
- 51 ongoing
Catalogue
ConcizuTrace™ ELISA Ref DEN240035
De Novo 510(k)Randox Calibration Serum Ref K053153
510(k) 510(k)Randox Rx Daytona Ref K024014
510(k) 510(k)Randox Immunoassay Control Ref K040379
510(k) 510(k)HBA1C Control, Level 1 And Level 2 Ref K131999
510(k) 510(k)Randox Apolipoprotein Calibrator Ref K023158
510(k) 510(k)Rx Imola Ref K052914
510(k) 510(k)Randox Lipoprotein Ref K011568
510(k) 510(k)
Company details
- FDA FEI number
- 3004493545
- Address
- 36 / 44 LARGY ROAD, CRUMLIN, COUNTY ANTRIM Antrim and Newtownabbey
FDA recalls
Recalls initiated per year
- 2017 3
- 2018 1
- 2019 0
- 2020 0
- 2021 0
- 2022 0
- 2023 1
- 2024 0
- 2025 0
- 2026 0
2023
- 1 Feb 2023 Z-1286-2023 Class II Ongoing The Antibody (R2 reagent) is showing a positive bias compared to previous batches on patient samples. Quality Controls do not show the same bias and will be within range
2018
- 4 May 2018 Z-2059-2018 Class II Terminated Abnormal premature termination of the software could affect the use of the analyser when running patient samples. The impact being a delay in reporting test results.
2017
- 11 Aug 2017 Z-0969-2018 Class III Terminated The ACTH in Immunoassay Premium and Premium Plus quality control does not meet the quoted reconstituted stability claim in the product IFU.
- 11 Aug 2017 Z-0970-2018 Class III Terminated The ACTH in Immunoassay Premium and Premium Plus quality control does not meet the quoted reconstituted stability claim in the product IFU.
- 27 Apr 2017 Z-2167-2017 Class III Terminated According to Randox Laboratories an investigation indicates a labelling error for 2 of the test methods listed for quantification of Total Protein (urine). The values for the mean of all instruments are incorrect by a factor of 10. Instrument specific values are correct. This does not affect the performance or stability claims of the product.
As control results will be outside of the quoted range this may result in a delay in reporting the sample test results.
However as the correct instrument specific means are also included in the value sheet this delay is unlikely. Customers have been referred to their Medical Director for further advice
Full distribution text
Frequently asked questions
How many devices does RANDOX LABORATORIES LIMITED have in the registry?
The registry currently lists 8 devices for RANDOX LABORATORIES LIMITED. Devices recorded under merged duplicate company entries are counted once.
Which registries list RANDOX LABORATORIES LIMITED's devices?
Among its 8 most recently registered devices, RANDOX LABORATORIES LIMITED has devices listed in FDA 510(k) (8 devices).
What risk classes do RANDOX LABORATORIES LIMITED's devices fall under?
Among its 8 most recently registered devices, the classes recorded for RANDOX LABORATORIES LIMITED's devices are Class I and Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for RANDOX LABORATORIES LIMITED?
FDA recall records list 5 recalls initiated by RANDOX LABORATORIES LIMITED, the most recent initiated on 2023-02-01. 1 of them is recorded as ongoing. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from RANDOX LABORATORIES LIMITED in the registry?
The most recently registered devices listed for RANDOX LABORATORIES LIMITED include ConcizuTrace™ ELISA, RANDOX CALIBRATION SERUM, RANDOX RX DAYTONA and RANDOX IMMUNOASSAY CONTROL.