Changeflow GovPing Pharma & Drug Safety Siemens RAPIDPoint 500 Blood Gas Systems Recall
Urgent Enforcement Removed Final

Siemens RAPIDPoint 500 Blood Gas Systems Recall

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Filed March 17th, 2026
Detected March 17th, 2026
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Summary

Health Canada has issued a Type II recall for Siemens RAPIDPoint 500 Blood Gas Systems due to Measurement Cartridges potentially being exposed to temperatures outside specified storage conditions during transport. This may affect cartridge performance, and affected healthcare providers should contact the manufacturer.

What changed

Health Canada has issued a Type II recall for Siemens RAPIDPoint 500 Blood Gas Systems, specifically the Measurement Cartridge component, due to potential exposure to temperatures below specified storage conditions during transport. This issue may adversely affect the performance of the affected cartridges, compromising their quality. The recall affects multiple lot and model numbers, and Siemens Healthcare Diagnostics Inc. is identified as the company involved.

Healthcare providers who have received affected Measurement Cartridges are advised to contact the manufacturer for additional information. While no specific compliance deadline or penalty is mentioned, the recall indicates a potential risk to patient care due to compromised diagnostic accuracy. Affected parties should review their inventory and contact Siemens Healthcare Diagnostics Inc. to understand the extent of the issue and any recommended actions.

What to do next

  1. Review inventory for affected Siemens RAPIDPoint 500 System - Lactate Measurement Cartridges.
  2. Contact Siemens Healthcare Diagnostics Inc. for additional information regarding the affected cartridges.

Source document (simplified)

Health product recall

RAPIDPoint® 500 Blood Gas Systems

Brand(s)

Siemens Healthcare Diagnostics Inc.

Last updated

2026-03-17

Summary

Product Rapidpoint 500 System - Lactate Issue Medical devices - Performance What to do Contact the manufacturer if you require additional information.

Affected products

| Affected products | Lot or serial number | Model or catalogue number |
| --- | --- | --- |
| Rapidpoint 500 System - Lactate | More than 10 numbers, contact manufacturer. | 10844813 |
| Rapidpoint 500 System - Lactate | More than 10 numbers, contact manufacturer. | 10491447 |
| Rapidpoint 500 System - Lactate | More than 10 numbers, contact manufacturer. | 10491448 |

Issue

Siemens Healthineers has confirmed that a limited number of Measurement Cartridge experienced exposure to temperatures below the specified storage conditions during transport.

Exposure to temperatures outside the acceptable range may adversely affect the performance of the affected Measurement Cartridge. Consequently, the quality of these cartridges cannot be assured. Our records indicate you received Measurement Cartridge(s) affected by this issue.

Additional information

Details

Original published date:

2026-03-17

Alert / recall type Health product recall Category Health products - Medical devices - Chemistry Companies Siemens Healthcare Diagnostics Inc.

511 Benedict Ave, Tarrytown, New York, United States, 10591

Published by Health Canada Audience General public Healthcare Industry Recall class Type II Recall date

2026-03-05

Identification number RA-81738

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Classification

Agency
Health Canada
Filed
March 17th, 2026
Instrument
Enforcement
Legal weight
Binding
Stage
Final
Change scope
Substantive

Who this affects

Applies to
Healthcare providers Manufacturers
Geographic scope
ca

Taxonomy

Primary area
Healthcare
Operational domain
Compliance
Topics
Medical Devices Product Safety

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