Recall Z-1267-2014 ยท NJT Immunohistochemistry Reagents And Kits
AMS Diagnostics, LLC
AMS BUN UREA NITROGEN For the In vitro quantitative determination of Urea Nitrogen in serum Quantitative determination of Bun in serum.
| Date | Mar 21, 2014 (initiated Feb 11, 2014) |
| Status | Terminated |
| Reason | Marketing the devices outside 510(k) requirements |
| Root cause | No Marketing Application |
| Action | 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. |
| Quantity | 167 kits |
| Distribution | Nationwide Distribution including FL, GA, MD, CA, NC, MA, SC, WY, and TX. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.