Recall Z-2202-2015 ยท JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Abbott Laboratories
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.
| Date | Jul 22, 2015 (initiated Jun 11, 2015) |
| Status | Terminated |
| Reason | The ARCHITECT c8000 instrument contains tubing that does not meet specifications and has the potential to leak. |
| Root cause | Mixed-up of materials/components |
| Action | 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 |
| Quantity | 5 units |
| Distribution | US Nationwide Distribution in the states of CA, AL, NY and WI. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K980367 | AEROSET SYSTEM Abbott Laboratories, Apr 1, 1998 |