Immunoglobulin A is an in vitro diagnostic assay for the quantitative… — Class II medical device recall Z-1988-2019
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-1988-2019 |
|---|---|
| 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 | 12,995 kits |
Product
Immunoglobulin A is an in vitro diagnostic assay for the quantitative determination of immunoglobulin A in human serum or plasma. Antigen in the sample bonds to the specific antibody in the reagent, forming an immune complex. The immune complex causes an increase in light scattering, measured by reading turbidity at 700 nm, which correlates with the concentration of immunoglobulin A 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-1988-2019. 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.