Apolipoprotein A1 is an in vitro diagnostic assay for the… — Class II medical device recall Z-1991-2019
Terminated recall by Abbott Laboratories, Inc, reported 2019-07-31, distributed nationwide. An update to the Reagents and Specimen Collection and Handling/Preparation for Analysis sections of the IFU wa
| Recall number | Z-1991-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Abbott Laboratories, Inc, Irving, TX, United States |
| Recall initiated | 2018-05-16 |
| Classified | 2019-07-19 |
| Reported by FDA | 2019-07-31 |
| Terminated | 2021-08-16 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AT, AU, BD, BE, BG, BO, BR, CA, CH, CL, CN, CR, CW, CY, CZ, DE, DK, DZ, EC, EE, EG, ES, FI, FR, GB, GR, HK, HN, HR, IE, IL, IN, IQ, IT, JM, JO, KE, KR, KW, LB, LT, LU, LV, MA, MX, MY, NL, NO, NZ, OM, PA, PE, PH, PK, PL, PT, PY, QA, RO, RS, RU, SA, SE, SG, SI, SK, TH, TN, TR, TT, TW, UY, VN, ZA |
| Quantity | 2,112 kits |
Product
Apolipoprotein A1 is an in vitro diagnostic assay for the quantitative determination of apolipoprotein A1 in human serum or plasma. Antibodies to apolipoprotein A1 combine with apolipoprotein A1 in the sample to form insoluble immune complexes. The immune complexes cause an increase in light scattering (turbidity). The resulting increase in sample turbidity, measured at 804 nm, is directly proportional to the concentration of apolipoprotein A1 in the sample.
Reason for recall
An update to the Reagents and Specimen Collection and Handling/Preparation for Analysis sections of the IFU was required due to different issues with the various products.
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-1991-2019. 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.