Recall Z-1104-2019— Abbott Laboratories, Inc
Class II · Terminated
Class II FDA medical device recall by Abbott Laboratories, Inc, initiated 2018-07-17, terminated 2020-09-23. It names one FDA 510(k) clearance: K980367. Product: Abbott ARCHITECT c16000 Processing Module, List No. 03L77 - Product Usage: The Abbott ARCHITECT System is intended for In Vitro diagnostic use only. The Abbott ARCHITECT Clinical Chemistry Systems are designed to perform automated chemistry tests, utilizing photometry and potentiometric technology. The ARCHITECT c4000, c8000, c16000 sample pipettor assemblies include a fluid sense/pressure monitoring system that helps identify errors in aspiration.. Reason: There is a potential to generate incorrect results on the instrument if particular error codes are not resolved before transitioning to the Running status..
- Recalling firm
- Abbott Laboratories, Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2018-07-17
- Terminated
- 2020-09-23
- Firm location
- Irving, TX, 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
Abbott ARCHITECT c16000 Processing Module, List No. 03L77 - Product Usage: The Abbott ARCHITECT System is intended for In Vitro diagnostic use only. The Abbott ARCHITECT Clinical Chemistry Systems are designed to perform automated chemistry tests, utilizing photometry and potentiometric technology. The ARCHITECT c4000, c8000, c16000 sample pipettor assemblies include a fluid sense/pressure monitoring system that helps identify errors in aspiration.
Reason for recall
There is a potential to generate incorrect results on the instrument if particular error codes are not resolved before transitioning to the Running status.
Data sourced from openFDA. This site is unofficial and independent of the FDA.