# Hcy HY4036

> Active: United States. Medical device record on deviCERTS, compiled from public registries.

- Canonical page: <https://devicerts.com/devices/hcy-hy4036>
- Manufacturer: [Randox Laboratories, Ltd.](https://devicerts.com/manufacturers/randox-laboratories-ltd)
- Name in the registry: HCY HY4036
- Device class: Class II (US FDA)
- FDA product code: LPS
- GMDN: Homocysteine IVD, reagent (53751)

## Registrations and authorizations

- **GUDID** · GUDID listing · United States · UDI-DI 05055273208894 · listed 2016-09-24 · status: Listed (GUDID: in commercial distribution)
- **GUDID** · FDA 510(k) · United States · K083222 · decision 2009-07-31 · decision SESE · status: Active · from GUDID

## Recalls

- Z-0742-2020 · Class II · ongoing · initiated 2019-09-16: There is a potential performance issue as detected by an under-recovery of sample results during routine testing.
- Z-0743-2020 · Class II · ongoing · initiated 2019-09-16: There is a potential performance issue as detected by an under-recovery of sample results during routine testing.
- Z-0744-2020 · Class II · ongoing · initiated 2019-09-16: There is a potential performance issue as detected by an under-recovery of sample results during routine testing.
- Z-2063-2016 · Class II · terminated · initiated 2015-04-03: Deterioration in performance of the Liquid Stable (LS) 2-Part HOMOCYSTEINE REAGENT resulting in under recovery. The manufacturer has indicated that the HOMOCYSTEINE REAGENT lot listed above shows deterioration in assay performance manifesting itself by under recovery of Homocysteine in Controls and Patient Samples. The cause of this deterioration has been attributed to a loss of reductant activity in Reagent 1. Testing performed indicated that the affected lot is at the limit of acceptable clinical performance. This observation was consistent across the reportable range of the assay. For this reason, do not continue to use affected reagent lot. Test data generated to date will be acceptable where validity control specifiCations have been met.
- Z-1946-2015 · Class II · terminated · initiated 2015-03-20: Deterioration in performance of the Liquid Stable (LS) 2-Part HOMOCYSTEINE REAGENT resulting in under recovery.

## Identity

- Trade name: HCY [FDA GUDID (AccessGUDID)]
- Generic name: Homocysteine IVD, reagent [FDA GUDID (AccessGUDID)]
- Model / Ref / Catalog: HY4036 [FDA GUDID (AccessGUDID)]

## Identifiers

- Primary DI / UDI-DI: 05055273208894 [FDA GUDID (AccessGUDID)]
- 510(k) Number: K083222 [FDA GUDID (AccessGUDID)]
- FDA product code: LPS [FDA GUDID (AccessGUDID)]
- GMDN term: Homocysteine IVD, reagent (53751) [FDA GUDID (AccessGUDID)]

## Classification

- Device class: Class II [FDA GUDID (AccessGUDID)]
- Regulation number: 862.1377 [FDA GUDID (AccessGUDID)]
- GUDID distribution status: In Commercial Distribution [FDA GUDID (AccessGUDID)]

## Properties

- Single use: Yes [FDA GUDID (AccessGUDID)]
- Prescription use: Yes [FDA GUDID (AccessGUDID)]
- Convenience kit: Yes [FDA GUDID (AccessGUDID)]
- Lot / batch number: Yes [FDA GUDID (AccessGUDID)]
- Expiration date: Yes [FDA GUDID (AccessGUDID)]
- Supplied sterile: No [FDA GUDID (AccessGUDID)]
- Sterilise before use: No [FDA GUDID (AccessGUDID)]
- Implantable: No [FDA GUDID (AccessGUDID)]
- Contains latex: No [FDA GUDID (AccessGUDID)]
- Over-the-counter: No [FDA GUDID (AccessGUDID)]
- Combination product: No [FDA GUDID (AccessGUDID)]
- HCT/P: No [FDA GUDID (AccessGUDID)]
- Premarket exempt: No [FDA GUDID (AccessGUDID)]
- Serial number: No [FDA GUDID (AccessGUDID)]
- Manufacturing date: No [FDA GUDID (AccessGUDID)]

## Source and citation

- Cite as: Hcy HY4036, Randox Laboratories, Ltd. deviCERTS medical device catalogue. https://devicerts.com/devices/hcy-hy4036 (data as of 2026-11-14).
- Data sources: [FDA GUDID (AccessGUDID)](https://accessgudid.nlm.nih.gov/), [FDA recalls](https://open.fda.gov/apis/device/recall/)
- Registry records last synced: 2026-10-22
- Statuses computed as of: 2026-11-14
- JSON: <https://devicerts.com/devices/hcy-hy4036.json>
- Licence: [CC BY 4.0](https://creativecommons.org/licenses/by/4.0/). The deviCERTS layout and text are licensed under CC BY 4.0. Registry data remain under their source terms: U.S. FDA data (openFDA, AccessGUDID) are U.S. public domain; EUDAMED data are subject to the European Commission reuse terms.
- Attribution: DevicErts, https://devicerts.com/devices/hcy-hy4036
- Compiled by deviCERTS (devicerts.com) from public medical device registries (EUDAMED, European Commission; U.S. FDA via openFDA; AccessGUDID, U.S. National Library of Medicine). deviCERTS is not an official register and gives no regulatory advice: the record in the registry itself prevails.