Reported Apr 15, 2020 · Terminated
ARCHITECT C System Mixer - Product Usage: The ARCHITECT Clinical Chemistry System is designed to perform automated…
Abbott Laboratories, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Abbott Laboratories, Inc · 1921 Hurd Dr · Irving, TX · 75038-4313
Is this the product you have?
- ARCHITECT
- C System Mixer - Product UsageThe 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
- Lot codes and dates
LN 09D59-01LN 09D59-02LN 09D59-03
- Amount recalled
- 09D59-01, 1010 products, 09D59-02, 25156 products, 09D59-03 13976 products
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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