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U.S. Department of Health and Human Services

Class 2 Device Recall AMS AST

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 Class 2 Device Recall AMS ASTsee related information
Date Initiated by FirmFebruary 11, 2014
Date PostedMarch 21, 2014
Recall Status1 Terminated 3 on September 29, 2016
Recall NumberZ-1269-2014
Recall Event ID 67599
Product Classification Immunohistochemistry reagents and kits - Product Code NJT
ProductAMS 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
For Additional Information ContactSamuel A. Burgos
954-217-0040
Manufacturer Reason
for Recall		Marketing the devices outside 510(k) requirements
FDA Determined
Cause 2		No Marketing Application
ActionAMS 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 Commerce116 kits
DistributionNationwide Distribution including FL, GA, MD, CA, NC, MA, SC, WY, and TX.
Total Product Life CycleTPLC Device Report
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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