FDAFDA · Food and drugs·Recall number Z-2202-2015
ARCHITECT c8000 System List Number 01G06-98 Product Usage: The Abbott ARCHITECT cSystem is intended for In Vitro diagnostic use only. It is designed to perform automated: chemistry tests, utilizing photometry and potentiometric technology.
Published July 29, 2015 · Recall initiated: June 11, 2015
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
The ARCHITECT c8000 instrument contains tubing that does not meet specifications and has the potential to leak.
What to do
Voluntary: Firm initiated · Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recall details
- Manufacturer
- Abbott Laboratories
- Distributor
- US Nationwide Distribution in the states of CA, AL, NY and WI.
- Lot
- Serial Numbers: C802239, C802312, C802260, C802447, C801911
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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