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Class 2 Device Recall AMS AST |
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Date Initiated by Firm |
February 11, 2014 |
Date Posted |
March 21, 2014 |
Recall Status1 |
Terminated 3 on September 29, 2016 |
Recall Number |
Z-1269-2014 |
Recall Event ID |
67599 |
Product Classification |
Immunohistochemistry reagents and kits - Product Code NJT
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Product |
AMS AST For the In vitro quantitative determination of AST in serum
Quantitative determination of AST in serum. |
Code Information |
Model Numbers: 40072, 40146, 80146. Lot codes: 131083, 131084, 131085, 131086, 131087, 131088, 131089, 1310810, 1310811, 1310812, 1310813, 1310814, 1310815, 141081. |
Recalling Firm/ Manufacturer |
AMS Diagnostics, LLC 1790 N Commerce Pkwy Weston FL 33326-3204
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For Additional Information Contact |
Samuel A. Burgos 954-217-0040
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Manufacturer Reason for Recall |
Marketing the devices outside 510(k) requirements
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FDA Determined Cause 2 |
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 in Commerce |
116 kits |
Distribution |
Nationwide Distribution including FL, GA, MD, CA, NC, MA, SC, WY, and TX. |
Total Product Life Cycle |
TPLC Device Report
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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