Z-2202-2015 Class II Terminated
FDA device recall Z-2202-2015 was initiated by Abbott Laboratories on Jun 11, 2015 and is designated Class II. Reason for recall: The ARCHITECT c8000 instrument contains tubing that does not meet specifications and has the potential to leak. The recall status is terminated (terminated Feb 9, 2016). Affected quantity: 5 units.
Recall Details
- Product Type
- Devices
- Report Date
- Jul 29, 2015
- Initiation Date
- Jun 11, 2015
- Termination Date
- Feb 9, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 5 units
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.
Distribution Pattern
US Nationwide Distribution in the states of CA, AL, NY and WI.
Code Information
Serial Numbers: C802239, C802312, C802260, C802447, C801911
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-2202-2015
- openFDA file date
- Oct 27, 2026
- Loaded by RegDataLab
- Oct 29, 2026