AMS BUN UREA NITROGEN For the In vitro quantitative determination of Urea Nitrogen in serum Quantitative determination of Bun in serum.
- Company
- Ams Diagnostics, Llc
- Recall Initiated
- February 11, 2014
- Posted
- March 21, 2014
- Terminated
- September 29, 2016
- Recall Number
- Z-1267-2014
- Quantity
- 167 kits
- Firm Location
- Weston, FL
Reason for Recall
Marketing the devices outside 510(k) requirements
Distribution
Nationwide Distribution including FL, GA, MD, CA, NC, MA, SC, WY, and TX.
Lot / Code Info
Model Numbers: 40072, 40146, 81046. Lot codes: 131083, 131084, 131085, 131086, 131087, 131088, 131089, 1310810, 1310811, 1310812, 1310813, 1310814, 1310815, 141081.
Root Cause
No Marketing Application
Action Taken
AMS Diagnostics sent a Recall Notification letter dated February 11, 2014 to all affected customers. The letter instructed the customers to: 1) Review their inventory for the lots listed and if they currently have them, to discard and notify the firm for a replacement. 2) If they don't have the lots listed, please check the box, sign, date and return the letter via fax at (954) 217-0046 or email to dj@amsdiagnostics.com. Customers with questions were instructed to call 954-217-0040 ext. 302. For questions regarding this recall call 954-217-0040.