ARCHITECT C System Mixer — Class II medical device recall Z-1671-2020
Terminated recall by Abbott Laboratories, Inc, reported 2020-04-15, distributed nationwide. Mixer blade may separate from mixer due to the screw and nut failure and detachment. As a result of the mixer
| Recall number | Z-1671-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Abbott Laboratories, Inc, Irving, TX, United States |
| Recall initiated | 2019-05-01 |
| Classified | 2020-04-06 |
| Reported by FDA | 2020-04-15 |
| Terminated | 2021-07-02 |
| Distributed | Nationwide (US) |
| Countries outside the US | GB |
| Reason classes | device malfunction |
Product
ARCHITECT C System Mixer - Product Usage: The ARCHITECT Clinical Chemistry System is designed to perform automated chemistry tests, utilizing photometry and potentiometric technology. The mixer is a component and it is used on all ARCHITECT Clinical Chemistry systems to mix the sample with the reagent inside of the cuvettes.
Reason for recall
Mixer blade may separate from mixer due to the screw and nut failure and detachment. As a result of the mixer blade missing, the sample and reagent are inadequately mixed.
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-1671-2020. 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.