ARCHITECT STAT High Sensitive Troponin-I Calibrators — Class III medical device recall Z-1360-2019
Terminated recall by Abbott Laboratories, reported 2019-05-22. Devices were delivered without the required dry ice.
| Recall number | Z-1360-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Abbott Laboratories, Abbott Park, IL, United States |
| Recall initiated | 2019-04-09 |
| Classified | 2019-05-16 |
| Reported by FDA | 2019-05-22 |
| Terminated | 2019-12-20 |
| Countries outside the US | LV |
| Quantity | 3 units |
| Lot numbers | 93284UIOO |
Product
ARCHITECT STAT High Sensitive Troponin-I Calibrators - Product Usage: The ARCHITECT STAT High Sensitive Troponin-I Controls are for the estimation of test precision and the detection of systematic analytical deviations of the ARCHITECT i System with STAT protocol capability when used for the quantitative determination of cardiac troponin I (cTnI) in human serum and plasma with the ARCHITECT STAT High Sensitive Troponin-I reagent kit.
Reason for recall
Devices were delivered without the required dry ice.
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-1360-2019. 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.