Recall Z-1269-2014— AMS Diagnostics, LLC
Class II · Terminated
Class II FDA medical device recall by AMS Diagnostics, LLC, initiated 2014-02-11, terminated 2016-09-29. FDA's recall record names no specific 510(k) clearance for this event. Product: AMS AST For the In vitro quantitative determination of AST in serum Quantitative determination of AST in serum.. Reason: Marketing the devices outside 510(k) requirements.
- Recalling firm
- AMS Diagnostics, LLC
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2014-02-11
- Terminated
- 2016-09-29
- Firm location
- Weston, FL, United States
Product description
AMS AST For the In vitro quantitative determination of AST in serum Quantitative determination of AST in serum.
Reason for recall
Marketing the devices outside 510(k) requirements
Data sourced from openFDA. This site is unofficial and independent of the FDA.