Recall Z-1671-2020— Abbott Laboratories, Inc
Class II · Terminated
Class II FDA medical device recall by Abbott Laboratories, Inc, initiated 2019-05-01, terminated 2021-07-02. It names one FDA 510(k) clearance: K980367. 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..
- Recalling firm
- Abbott Laboratories, Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2019-05-01
- Terminated
- 2021-07-02
- Firm location
- Irving, TX, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.