Recall Z-1267-2014— 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 BUN UREA NITROGEN For the In vitro quantitative determination of Urea Nitrogen in serum Quantitative determination of Bun 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 BUN UREA NITROGEN For the In vitro quantitative determination of Urea Nitrogen in serum Quantitative determination of Bun 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.