PlainRecalls
FDA Devices Moderate Class II Terminated

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.

Reported: July 29, 2015 Initiated: June 11, 2015 #Z-2202-2015

Product Description

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.

Reason for Recall

The ARCHITECT c8000 instrument contains tubing that does not meet specifications and has the potential to leak.

Details

Recalling Firm
Abbott Laboratories
Units Affected
5 units
Distribution
US Nationwide Distribution in the states of CA, AL, NY and WI.
Location
Abbott Park, IL

Frequently Asked Questions

What product was recalled?
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.. Recalled by Abbott Laboratories. Units affected: 5 units.
Why was this product recalled?
The ARCHITECT c8000 instrument contains tubing that does not meet specifications and has the potential to leak.
Which agency issued this recall?
This recall was issued by the FDA Devices on July 29, 2015. Severity: Moderate. Recall number: Z-2202-2015.