FDA DevicesClass II
Dimension Creatinine Flex reagent cartridge. Material Number: 10872079.
Published: May 6, 2026Recall ID: Z-1980-2026Category: devicesCountry: US
Reason for Recall / 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
Product Description & Identification
Dimension Creatinine Flex reagent cartridge. Material Number: 10872079.
Additional Source Details
| Field | Value |
|---|---|
| City | Newark |
| State | DE |
| Event id | 98666 |
| Address 1 | 500 Gbc Dr |
| Code info | Material Number: 10872079. Model Number: DF33B. UDI: (01)00630414595009(10)GA6307(17)20261103, (01)00630414595009(10)BA7005(17)20270105. Lot Numbers: GA6307, BA7005. |
| Postal code | 19702-2466 |
| Report date | 20260506 |
| Product type | Devices |
| Product quantity | 18,080 units |
| Reason for recall | 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 |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260318 |
| Initial firm notification | Letter |
| Center classification date | 20260428 |
Overview
- Recalling FirmSiemens Healthcare Diagnostics, Inc.
- StatusOngoing
- Risk LevelClass II
- DistributionWorldwide distribution - US Nationwide and the countries of Argentina, Australia, Austria, Bahamas, Brazil, Cambodia, Canada, Chile, China, Columbia, Costa Rica, Ecuador, Egypt, Germany, Honduras, India, Indonesia, Korea, Kuwait, Lebanon, Malaysia, Mexico, Nicaragua, Pakistan, Paraguay, Philippines, Qatar, Saudi Arabia, Serbia, Slovenia, South Africa, Sri Lanka, Taiwan, Thailand, U.A.E., Ukraine, Uruguay, Vietnam, Yemen.