Abbott ARCHITECT Creatine Kinase — Class II medical device recall Z-1076-2019
Terminated recall by Abbott Laboratories, Inc, reported 2019-04-10, distributed nationwide. The product has a stability issue which may lead to an error code indicating "Unable to calculate result, reac
| Recall number | Z-1076-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Abbott Laboratories, Inc, Irving, TX, United States |
| Recall initiated | 2018-07-18 |
| Classified | 2019-03-30 |
| Reported by FDA | 2019-04-10 |
| Terminated | 2020-08-13 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AT, AU, BE, BG, BM, BR, CA, CH, CL, CN, CO, CR, CW, CZ, DE, DK, DZ, EC, EE, EG, ES, FI, FR, GB, GR, GT, HK, HR, HU, ID, IE, IL, IN, IQ, IT, JM, KR, KW, KY, LB, LT, LU, LV, MA, MX, MY, NL, NO, NZ, OM, PH, PK, PL, PT, PY, QA, RO, RS, RU, SA, SE, SG, SK, SV, TH, TN, TR, TT, TW, UY, VN, ZA |
| Quantity | 30 kits |
| Reason classes | specification failure |
| UPC / GTIN / UDI-DI | 00380740101176 |
| Lot numbers | 99633UN18 |
| Model numbers | 7D6341 |
| Expiration dates | 2019-01-02 |
Product
Abbott ARCHITECT Creatine Kinase, IVD, REF 7D6341.
Reason for recall
The product has a stability issue which may lead to an error code indicating "Unable to calculate result, reaction check failure" and/or Quality Control results out of range low.
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-1076-2019. 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.