FDA Device recall Z-1980-2026
Dimension Creatinine Flex reagent cartridge
- FDA Device
- Class II
- ongoing
- Published 2026-05-06
On 2026-05-06 the FDA classified a Class II recall of Dimension Creatinine Flex reagent cartridge by Siemens Healthcare Diagnostics, citing siemens Healthcare Diagnostics is recalling certain lots of Dimension Creatinine Flex reagent cartridge (Dimension CRE2) because a potential imprecision in the Dimension CRE2 qual….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1980-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-03-18 |
| Published | 2026-05-06 |
| Last updated | 2026-09-13 11:58 UTC |
| Company | Siemens Healthcare Diagnostics |
| Distribution | US |
Product
Dimension Creatinine Flex reagent cartridge. Material Number: 10872079.
Reason
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
Identifiers
| code_info | Material Number: 10872079. Model Number: DF33B. UDI: (01)00630414595009(10)GA6307(17)20261103, (01)00630414595009(10)BA…Material Number: 10872079. Model Number: DF33B. UDI: (01)00630414595009(10)GA6307(17)20261103, (01)00630414595009(10)BA7005(17)20270105. Lot Numbers: GA6307, BA7005. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:58 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1980-2026%22
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