Recall Z-2202-2015
Abbott Laboratories · initiated June 11, 2015
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
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.
Codes / lots: Serial Numbers: C802239, C802312, C802260, C802447, C801911
Reason for recall
The ARCHITECT c8000 instrument contains tubing that does not meet specifications and has the potential to leak.
FDA-determined cause: Mixed-up of materials/components
Action taken
Abbott notified thier affected consignees via phone or visit on 5/29/15. A follow up Product Recall notification letter dated June 4, 2015 was sent to affected customers. The letter identified the affected product, problem and actions to be taken. The letter instructed customers to immediately discontinue use of the product, Abbott representative will be make all necessary arrangements for replacing your impacted instruments(s), follow your laboratory protocol regarding the need to review previously reported patient results and retain this notification for laboratory records. For questions contact Customer Service at 1-877-4ABBOTT.
Details
- Recall number
- Z-2202-2015
- Initiated
- June 11, 2015
- Posted by FDA
- July 22, 2015
- Terminated
- February 9, 2016
- Product code
- JJE – Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
- Quantity
- 5 units
- Distribution
- US Nationwide Distribution in the states of CA, AL, NY and WI.
- Recalling firm
- Abbott Laboratories, Abbott Park, IL