# BCS® XP System 10459330

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

- Canonical page: <https://devicerts.com/devices/bcs-r-xp-system-ovob03>
- Manufacturer: [Siemens Healthcare Diagnostics Products Ltd](https://devicerts.com/manufacturers/siemens-healthcare-diagnostics-products-ltd) (FDA registration: Germany)
- Device class: Class II (US FDA)
- FDA product code: GKP, JPA
- GMDN: Coagulation analyser IVD, laboratory (56689)

## Registrations and authorizations

- **GUDID** · GUDID listing · United States · UDI-DI 00630414945514 · listed 2016-09-24 · status: Listed (GUDID: in commercial distribution)
- **GUDID** · FDA 510(k) · United States · K970431 · decision 1997-05-05 · decision SESE · status: Active · from GUDID

## Recalls

- Z-1435-2021 · Class II · terminated · initiated 2021-03-02 · matched through shared submission K970431, may concern other models: Siemens Healthcare Diagnostics Products GmbH has confirmed that the BCS XP System may be affected by a potential Emicizumab carryover on patient samples.
- Z-0825-2016 · Class II · terminated · initiated 2016-01-14 · matched through shared submission K970431, may concern other models: False short clotting times for PT on BCS and BCS XP with Dade Innovin can occur. This has also an effect for false low PT INR values. These false short clotting times were observed only with turbid, hemolytic and/or icteric samples from intensive care patients. The corresponding reaction curves of these samples showed a pre-peak, which can lead to falsely short clotting time. The result was not flagged by the existing check algorithms.

## Identity

- Trade name: BCS® XP System [FDA GUDID (AccessGUDID)]
- Generic name: Coagulation analyser IVD, laboratory [FDA GUDID (AccessGUDID)]
- Model / Ref / Catalog: 10459330 [FDA GUDID (AccessGUDID)]; OVOB03 [FDA GUDID (AccessGUDID)]

## Identifiers

- Primary DI / UDI-DI: 00630414945514 [FDA GUDID (AccessGUDID)]
- 510(k) Number: K970431 [FDA GUDID (AccessGUDID)]
- FDA product code: GKP [FDA GUDID (AccessGUDID)]
- GMDN term: Coagulation analyser IVD, laboratory (56689) [FDA GUDID (AccessGUDID)]

## Classification

- Device class: Class II [FDA GUDID (AccessGUDID)]
- Regulation number: 864.5400 [FDA GUDID (AccessGUDID)]
- GUDID distribution status: In Commercial Distribution [FDA GUDID (AccessGUDID)]

## Properties

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

## Source and citation

- Cite as: BCS® XP System 10459330, Siemens Healthcare Diagnostics Products Ltd. deviCERTS medical device catalogue. https://devicerts.com/devices/bcs-r-xp-system-ovob03 (data as of 2026-11-15).
- 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: 2026-11-15
- JSON: <https://devicerts.com/devices/bcs-r-xp-system-ovob03.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/bcs-r-xp-system-ovob03
- 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.