Dimension Creatinine CRE2 Medical Device Recall
Summary
Health Canada issued a Class Type II medical device recall for Siemens Healthineers Dimension® Creatinine (CRE2) diagnostic reagents due to potential imprecision in quality control and patient sample results. Affected lots GA6307 and BA7005 (catalog 10872079) may produce inaccurate creatinine measurements on the Dimension system. Healthcare facilities using these products should immediately quarantine affected inventory and contact Siemens for return or replacement options.
What changed
Siemens Healthineers has initiated a recall for Dimension® Creatinine (CRE2) reagent lots GA6307 and BA7005 after confirming potential imprecision issues through customer complaint investigation. The defective lots may produce inaccurate quality control and patient results when used on the Dimension system, posing risks to clinical decision-making. This is a Type II recall classified by Health Canada.
Healthcare facilities and laboratories using the Dimension system must immediately identify and quarantine any remaining inventory of affected lots. Contact Siemens Healthcare Diagnostics directly to arrange for product return and replacement. Monitor patient results if testing was performed with these lots and consider repeat testing where clinically appropriate. No specific compliance deadline was stated; action should be taken as soon as possible given the potential patient safety implications.
What to do next
- Quarantine all Dimension® Creatinine (CRE2) inventory matching lots GA6307 and BA7005
- Contact Siemens Healthcare Diagnostics to arrange return or replacement of affected product
- Review recent patient results and consider repeat testing if clinically indicated
Archived snapshot
Apr 2, 2026GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.
Health product recall
Dimension® Creatinine (CRE2)
Brand(s)
Siemens Healthcare Diagnostics Inc.
Last updated
2026-04-02
Summary
Product Dimension® Creatinine (CRE2) Issue Medical devices - Performance What to do Contact the manufacturer if you require additional information.
Audience Healthcare Industry
Affected products
| Affected products | Lot or serial number | Model or catalogue number |
| --- | --- | --- |
| Dimension® Creatinine (CRE2) | GA6307 | 10872079 |
| Dimension® Creatinine (CRE2) | BA7005 | 10872079 |
Issue
Siemens Healthineers has confirmed, through investigation of customer complaints, a potential for imprecision in Dimension® Creatinine (CRE2) quality control (QC) and patient sample results when using lot numbers GA6307 and BA7005 on the dimension system.
Additional information
Details
Original published date:
2026-04-02
Alert / recall type Health product recall Category Health products - Medical devices - Chemistry Companies Siemens Healthcare Diagnostics Inc.
500 Gbc Drive, Newark, Delaware, United States, 19714
Published by Health Canada Audience Healthcare Industry Recall class Type II Recall date
2026-03-23
Identification number RA-81833
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Source
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