Dimension Lipase Flex¿ Reagent Cartridge — Class II medical device recall Z-1796-2018
Terminated recall by Siemens Healthcare Diagnostics, Inc., reported 2018-05-16. Calibration failure - confirmed a positive bias with LIPL lot FB8109 when compared to other Dimension LIPL lot
| Recall number | Z-1796-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Siemens Healthcare Diagnostics, Inc., Newark, DE, United States |
| Recall initiated | 2017-12-14 |
| Classified | 2018-05-10 |
| Reported by FDA | 2018-05-16 |
| Terminated | 2020-12-03 |
| UPC / GTIN / UDI-DI | 00842768025532 |
| Lot numbers | FB8109 |
| Model numbers | DF56 |
Product
Dimension Lipase Flex¿ Reagent Cartridge - ( Lipase-esterase, enzymatic, photometric, lipase)
Reason for recall
Calibration failure - confirmed a positive bias with LIPL lot FB8109 when compared to other Dimension LIPL lots. Lot FB8109 is not meeting Siemens internal specifications for lot-to-lot limits.
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-1796-2018. 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.