Dimension Lipase Flex Reagent Cartridge — Class II medical device recall Z-0465-2019
Terminated recall by Siemens Healthcare Diagnostics, Inc., reported 2018-11-21, distributed nationwide. There is lot to lot variability for QC and patient results when using the identified reagent cartridge lots.
| Recall number | Z-0465-2019 |
|---|---|
| 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 | 2018-09-07 |
| Classified | 2018-11-14 |
| Reported by FDA | 2018-11-21 |
| Terminated | 2020-11-16 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AT, AU, BD, BE, BG, BH, BR, BS, CA, CH, CL, CN, CO, CZ, DE, DK, DZ, EC, EG, ES, FR, GB, HN, HU, ID, IN, IT, JP, KR, KW, LB, LT, LV, MX, MY, NI, NO, NP, NZ, PE, PH, PL, PT, PY, QA, RO, RS, RU, SA, SI, SK, SV, TH, TR, TW, UY, ZA |
| Quantity | 18,396 |
| Lot numbers | GA9003, GA9038, GB9032, GD9002 |
| Model numbers | 10460277 |
Product
Dimension Lipase Flex Reagent Cartridge, Model Number 10460277 Product Usage: Dimension - The LIPL method is an in vitro diagnostic test for the quantitative measurement of lipase in human serum and plasma on the Dimension¿ clinical chemistry system.
Reason for recall
There is lot to lot variability for QC and patient results when using the identified reagent cartridge lots.
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-0465-2019. 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.