ADVIA Chemistry Lipase Reagent — Class II medical device recall Z-1457-2015
Terminated recall by Siemens Healthcare Diagnostics, Inc., reported 2015-04-29, distributed nationwide. Siemens internal investigation confirmed that current contamination avoidance settings do not prevent carryove
| Recall number | Z-1457-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Siemens Healthcare Diagnostics, Inc., Tarrytown, NY, United States |
| Recall initiated | 2015-03-23 |
| Classified | 2015-04-20 |
| Reported by FDA | 2015-04-29 |
| Terminated | 2015-12-18 |
| Distributed | Nationwide (US) |
| Countries outside the US | AR, AT, AU, BE, BR, CA, CH, CL, CN, CO, CY, CZ, DE, DZ, EE, EG, ES, FI, FR, GB, GR, HU, ID, IL, IN, IT, KR, LT, LU, LV, MX, MY, NL, NO, PE, PK, PL, PT, PY, RO, RS, SG, SI, SK, TH, TR, TW, VN, ZA |
| Quantity | 7,814 |
| Lot numbers | 318706, 332463 |
| Model numbers | 01984894, B01-4840-01 |
| Expiration dates | 2015-06-30 |
Product
ADVIA Chemistry Lipase Reagent , Catalog Number B01-4840-01 REF: 01984894.
Reason for recall
Siemens internal investigation confirmed that current contamination avoidance settings do not prevent carryover resulting in falsely elevated ADVIA Chemistry Lipase outlier results when running with Triglycerides, Triglycerides_2, Triglycerides_c, Cholesterol concentrated, and DLDL reagents.
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-1457-2015. 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.