Dimension Creatinine Flex reagent cartridge — Class II medical device recall Z-1980-2026
Ongoing recall by Siemens Healthcare Diagnostics, Inc., reported 2026-05-06, distributed nationwide. Siemens Healthcare Diagnostics is recalling certain lots of Dimension Creatinine Flex reagent cartridge (Dimen
| Recall number | Z-1980-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Siemens Healthcare Diagnostics, Inc., Newark, DE, United States |
| Recall initiated | 2026-03-18 |
| Classified | 2026-04-28 |
| Reported by FDA | 2026-05-06 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AT, AU, BR, BS, CA, CL, CN, CR, DE, EC, EG, HN, ID, IN, KR, KW, LB, LK, MX, MY, NI, PH, PK, PY, QA, RS, SA, SI, TH, TW, UA, UY, VN, ZA |
| Quantity | 18,080 units |
| UPC / GTIN / UDI-DI | 00630414595009 |
| Lot numbers | BA7005, GA6307 |
| Model numbers | DF33B |
Product
Dimension Creatinine Flex reagent cartridge. Material Number: 10872079.
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
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1980-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.