FDA Device recall Z-1671-2020
ARCHITECT C System Mixer - Product Usage: The ARCHITECT Clinical Chemistry System is designed to perform automated chemistry tests, utilizi…
- FDA Device
- Class II
- terminated
- Published 2020-04-15
On 2020-04-15 the FDA classified a Class II recall of ARCHITECT C System Mixer - Product Usage: The ARCHITECT Clinical Chemistry System is designed to perform automated chemistry tests, utilizi… by Abbott Laboratories, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1671-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-05-01 |
| Published | 2020-04-15 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Abbott Laboratories |
| Distribution | US |
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
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.
Identifiers
| code_info | LN 09D59-01, LN 09D59-02, LN 09D59-03 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1671-2020%22
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