ARCHITECT BNP Calibrators Ptoduct Usage: The ARCHITECT BNP… — Class III medical device recall Z-2078-2019
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-2078-2019 |
|---|---|
| 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 | 5,483 units |
| Reason classes | specification failure |
| UPC / GTIN / UDI-DI | 00380740017460, 00380740145255 |
| Lot numbers | 44K79318, 44K79418, 44K80818, 44K81018, 44K82018, 44K82118, 44K82618, 44K84119, 44K85119, 44K85219 |
| Expiration dates | 2019-12-17 |
Product
ARCHITECT BNP Calibrators Ptoduct Usage: The ARCHITECT BNP Calibrators are for the calibration of the ARCHITECT iSystem when used for the quantitative determination of human Btype 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-2078-2019. 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.