Abbott ARCHITECT C System Mixer Recall Due to Blade Separation Risk
Abbott is recalling ARCHITECT C System Mixers because the blade may separate from the mixer due to screw and nut failure, leading to inadequate mixing of samples and reagents.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves a mechanical failure leading to inadequate sample mixing, which is a risk-of-harm product issue where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
Abbott Laboratories, Inc. is recalling the ARCHITECT C System Mixer. This component is used on all ARCHITECT Clinical Chemistry systems to mix samples with reagents inside cuvettes. The recall involves lot numbers 09D59-01, 09D59-02, and 09D59-03.
The recall was initiated because the mixer blade may separate from the mixer due to screw and nut failure and detachment. If the mixer blade is missing, the sample and reagent are inadequately mixed, which can affect the performance of the automated chemistry tests.
The affected products were distributed worldwide and nationwide in the United States, including specific states and territories, as well as numerous international countries. Users of the ARCHITECT Clinical Chemistry System should check their equipment for the affected lot numbers and contact Abbott Laboratories for further instructions.
The recalled product
- 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…
- Manufacturer
- Abbott Laboratories, Inc
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- LN 09D59-01
- LN 09D59-02
- LN 09D59-03
Distribution
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