Lipase Reagent — Class II medical device recall Z-0131-2015
Terminated recall by Abbott Laboratories, Inc, reported 2014-11-05, distributed nationwide. Package inserts have incorrect SmartWash parameters for Triglyceride.
| Recall number | Z-0131-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Abbott Laboratories, Inc, Irving, TX, United States |
| Recall initiated | 2014-04-07 |
| Classified | 2014-10-27 |
| Reported by FDA | 2014-11-05 |
| Terminated | 2015-04-01 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AT, AU, BD, BE, BG, BR, CA, CH, CL, CN, CZ, DE, DO, DZ, EE, EG, ES, FR, GB, GR, GT, HR, HU, ID, IE, IL, IN, IQ, IT, JM, JO, KE, KR, KW, LB, LT, LU, LV, MA, NL, NO, NZ, PA, PH, PK, PL, PT, PY, QA, RO, RS, SA, SE, SI, TH, TN, TR, TT, TW, UY, ZA |
| Quantity | 11,916 units |
| Lot numbers | 43819UQ03, 43827UQ12, 43994UQ07, 44127UQ06, 44334UQ07, 44449UQ05, 44596UQ08, 44775UQ09, 44930UQ11 |
Product
Lipase Reagent, 7D80. Used to measure lipase in human serum on the Architect system.
Reason for recall
Package inserts have incorrect SmartWash parameters for Triglyceride.
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-0131-2015. 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.