# IRISpec CA/CB/CC URINE CHEMSITRY CONTROLS

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

- Canonical page: <https://devicerts.com/devices/irispec-800-7211-88673def>
- Manufacturer: [Beckman Coulter Ireland Inc.](https://devicerts.com/manufacturers/beckman-coulter-ireland-inc) (Ireland)
- Device class: Class I (US FDA)
- FDA product code: JJW
- GMDN: Multiple urine analyte IVD, control (30219)

## Registrations and authorizations

- **GUDID** · GUDID listing · United States · UDI-DI 10837461002611 · listed 2016-09-07 · status: Listed (GUDID: in commercial distribution)
- **GUDID** · FDA 510(k) · United States · K072640 · decision 2007-12-21 · decision SESE · status: Active · from GUDID

## Recalls

- Z-0093-2025 · Class III · ongoing · initiated 2024-07-16: Beckman Coulter has become aware of an increase in customer complaints for intermittent IRISpec CB negative glucose control failure, resulting in false positive control results when used in conjunction with iChemVELOCITY Urine Chemistry Strips (PNs 800-7204 and 800-7212) on the iChemVELOCITY Analyzer. This issue may delay the reporting of patient results, with a worst-case scenario of a delay in diagnosis or treatment of metabolic disorders, kidney function abnormalities, urinary tract infections, and liver function.
- Z-0777-2023 · Class II · ongoing · initiated 2022-11-18: Beckman Coulter has become aware of an increase in customer complaints generated for intermittent IRISpec CB glucose control false positive results when used in conjunction with iChemVelocity Urine Chemistry Strips PN 800-7212

## Identity

- Trade name: IRISpec [FDA GUDID (AccessGUDID)]
- Generic name: Multiple urine analyte IVD, control [FDA GUDID (AccessGUDID)]
- Model / Ref / Catalog: CA/CB/CC URINE CHEMSITRY CONTROLS [FDA GUDID (AccessGUDID)]; 800-7211 [FDA GUDID (AccessGUDID)]

## Identifiers

- Primary DI / UDI-DI: 10837461002611 [FDA GUDID (AccessGUDID)]
- 510(k) Number: K072640 [FDA GUDID (AccessGUDID)]
- FDA product code: JJW [FDA GUDID (AccessGUDID)]
- GMDN term: Multiple urine analyte IVD, control (30219) [FDA GUDID (AccessGUDID)]

## Classification

- Device class: Class I [FDA GUDID (AccessGUDID)]
- Regulation number: 862.1660 [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: IRISpec CA/CB/CC URINE CHEMSITRY CONTROLS, Beckman Coulter Ireland Inc. deviCERTS medical device catalogue. https://devicerts.com/devices/irispec-800-7211-88673def (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: 2026-10-23
- Statuses computed as of: 2026-11-14
- JSON: <https://devicerts.com/devices/irispec-800-7211-88673def.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/irispec-800-7211-88673def
- 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.