ARCHITECT SHBG Reagent The ARCHITECT SHBG assay is a chemiluminescent… — Class II medical device recall Z-2613-2017
Terminated recall by Abbott Laboratories, reported 2017-06-28, distributed nationwide. Firm has identified that ARCHITECT SHBG results generated with the Potassium EDTA specimen tube type may demon
| Recall number | Z-2613-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Abbott Laboratories, Abbott Park, IL, United States |
| Recall initiated | 2017-04-18 |
| Classified | 2017-06-19 |
| Reported by FDA | 2017-06-28 |
| Terminated | 2019-06-03 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AT, BB, BD, BE, BR, CA, CH, CL, CN, CO, CR, CY, CZ, DE, DK, EE, EG, ES, FI, FR, GB, GR, HR, HU, IE, IL, IN, IQ, IR, IT, JO, KR, KW, LB, LK, LT, LU, LV, MX, MY, NL, NO, OM, PH, PK, PL, PT, PY, QA, RO, RS, RU, SA, SE, SG, SI, SK, TH, TR, TW, UY, VN, ZA |
| Quantity | 7,981 kits |
| Reason classes | potency |
| Lot numbers | 00216F000, 00316F000, 00816I000, 00916I000, 00916L000, 01716G000, 01816E000, 01816G000, 01916E000, 07216I000, 07316I000 |
Product
ARCHITECT SHBG Reagent The ARCHITECT SHBG assay is a chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of sex hormone binding globulin (SHBG) in human serum and plasma on the ARCHITECT iSystem. The ARCHITECT SHBG assay is used as an aid in the diagnosis of androgen disorders.
Reason for recall
Firm has identified that ARCHITECT SHBG results generated with the Potassium EDTA specimen tube type may demonstrate a negative shift relative to results generated with serum. There is a potential for falsely decreased ARCHITECT SHBG results to be generated when using the ARCHITECT SHBG assay with the Potassium EDTA specimen tube type.
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-2613-2017. 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.