Recall Z-1269-2014 ยท NJT Immunohistochemistry Reagents And Kits
AMS Diagnostics, LLC
AMS AST For the In vitro quantitative determination of AST in serum Quantitative determination of AST 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 | 116 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.