ARCHITECT STAT Myoglobin Reagent Kit — Class II medical device recall Z-1476-2024
Ongoing recall by Abbott Laboratories, reported 2024-04-10, distributed nationwide. The reason for the recall is the failure of calibration and quality controls due to a manufacturing issue of m
| Recall number | Z-1476-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Abbott Laboratories, Abbott Park, IL, United States |
| Recall initiated | 2024-02-21 |
| Classified | 2024-04-04 |
| Reported by FDA | 2024-04-10 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, BE, BR, CH, CN, CZ, DE, FR, HU, IE, IL, IN, IT, JP, KR, LT, LU, LV, MA, MX, PL, PT, RO, RU, SA, SI, SK, TR, TT, TW, UY, VN, ZA |
| Quantity | 7,482 kits |
| Reason classes | labeling |
| UPC / GTIN / UDI-DI | 00380740003296, 00380740003302 |
| Lot numbers | 50808UN23, 60104UN23 |
| Expiration dates | 2024-11-30 |
Product
ARCHITECT STAT Myoglobin Reagent Kit, LN 2K43-25 and 2K43-20.
Reason for recall
The reason for the recall is the failure of calibration and quality controls due to a manufacturing issue of microparticles not meeting labeled claim. This may lead to incorrect myoglobin results and delayed diagnosis of myocardial infarction.
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-1476-2024. 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.