AMS BUN UREA NITROGEN For the In vitro quantitative determination of Urea Nitrogen in serum Quantitative determination of Bun in serum.
This recall has been terminated (originally issued March 21, 2014).
- 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
- Official Source
- View on FDA website ↗
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.