Recall Z-0131-2015— Abbott Laboratories, Inc
Class II · Terminated
Class II FDA medical device recall by Abbott Laboratories, Inc, initiated 2014-04-07, terminated 2015-04-01. FDA's recall record names no specific 510(k) clearance for this event. Product: Lipase Reagent, 7D80. Used to measure lipase in human serum on the Architect system.. Reason: Package inserts have incorrect SmartWash parameters for Triglyceride..
- Recalling firm
- Abbott Laboratories, Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2014-04-07
- Terminated
- 2015-04-01
- Firm location
- Irving, TX, United States
Product description
Lipase Reagent, 7D80. Used to measure lipase in human serum on the Architect system.
Reason for recall
Package inserts have incorrect SmartWash parameters for Triglyceride.
Data sourced from openFDA. This site is unofficial and independent of the FDA.