ARCHITECT BNP Controls Ptoduct Usage: The ARCHITECT BNP Controls are… — Class III medical device recall Z-2079-2019
Terminated recall by Abbott Laboratories, reported 2019-07-31, distributed nationwide. Presence of a time dependent, stability drift in patient and control results returned from ARCHITECT BNP testi
| Recall number | Z-2079-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Abbott Laboratories, Abbott Park, IL, United States |
| Recall initiated | 2019-05-24 |
| Classified | 2019-07-25 |
| Reported by FDA | 2019-07-31 |
| Terminated | 2021-04-01 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AT, BD, BE, BG, CA, CH, CL, CW, CY, CZ, DE, DK, DZ, EC, EE, ES, FI, FR, GB, GR, HN, HR, HU, IE, IL, IQ, IR, IT, JO, KW, KY, LB, LK, LT, LU, MA, NL, NO, OM, PA, PK, PL, PT, PY, RO, RS, SA, SG, SI, SK, SV, TN, TR, TT, VN, ZA |
| Quantity | 6,623 units |
| Reason classes | specification failure |
| UPC / GTIN / UDI-DI | 00380740017477, 00380740145262 |
| Lot numbers | 44K78918, 44K79518, 44K80918, 44K81118, 44K82718, 44K82818, 44K84219 |
Product
ARCHITECT BNP Controls Ptoduct Usage: The ARCHITECT BNP Controls are for the estimation of test precision and the detection of systematic analytical deviations of the ARCHITECT iSystem (reagents, calibrators and instrument), when used for the quantitative determination of human B type natriuretic peptide (BNP) in human EDTA plasma.
Reason for recall
Presence of a time dependent, stability drift in patient and control results returned from ARCHITECT BNP testing.
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-2079-2019. 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.