FDA Enforcement
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.
Recall: Z-2202-2015
·
Reported July 29, 2015
Enforcement
- Recall Number
- Z-2202-2015
- Event ID
- 71473
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Abbott Laboratories
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Report Date
- July 29, 2015
- Initiation Date
- June 11, 2015
- Classification Date
- July 22, 2015
- Termination Date
- February 9, 2016
- Address
- 100 Abbott Park Rd, N/A, Abbott Park, IL, 60064-3502, United States
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
The ARCHITECT c8000 instrument contains tubing that does not meet specifications and has the potential to leak.
Code Info
Serial Numbers: C802239, C802312, C802260, C802447, C801911
Distribution
US Nationwide Distribution in the states of CA, AL, NY and WI.
Quantity
5 units