Dimension Creatinine Flex reagent cartridge. Material Number: 10872079.
| Source | FDA Device Enforcement |
|---|---|
| Category | Medical Device |
| Severity | Medium |
| Status | ongoing |
| Recall date | March 18, 2026 |
| Reported | May 06, 2026 |
| Recalling firm | Siemens Healthcare Diagnostics, Inc. |
| Country / region | United States DE |
Hazard
Siemens Healthcare Diagnostics is recalling certain lots of Dimension Creatinine Flex reagent cartridge (Dimension CRE2) because a potential imprecision in the Dimension CRE2 quality control (QC) and patient sample results using lot numbers GA6307 and BA7005 on the Dimension System. This imprecision may lead to erroneously decreased or increased creatinine patient results
Affected products
- Dimension Creatinine Flex reagent cartridge. Material Number: 10872079.
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