AMS AST For the In vitro quantitative determination of AST in serum Quantitative determination of AST in serum.
FDA Recall Z-1269-2014 · Posted 2014-03-21
Recalling FirmAMS Diagnostics, LLC
Recall StatusTerminated
Product CodeNJT
Date Initiated2014-02-11
Date Terminated2016-09-29
Product Quantity116 kits
Reason for Recall
Marketing the devices outside 510(k) requirements
Firm 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 [email protected]. Customers with questions were instructed to call 954-217-0040 ext. 302.
For questions regarding this recall call 954-217-0040.
Root Cause
No Marketing Application
Distribution Pattern
Nationwide Distribution including FL, GA, MD, CA, NC, MA, SC, WY, and TX.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.