Recall Z-2202-2015— Abbott Laboratories
Class II · Terminated
Class II FDA medical device recall by Abbott Laboratories, initiated 2015-06-11, terminated 2016-02-09. It names one FDA 510(k) clearance: K980367. 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.. Reason: The ARCHITECT c8000 instrument contains tubing that does not meet specifications and has the potential to leak..
- Recalling firm
- Abbott Laboratories
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2015-06-11
- Terminated
- 2016-02-09
- Firm location
- Abbott Park, IL, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.