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FDA device recall Z-1267-2014 · posted 2014-03-21 · Terminated

Recall details

Recalling firm

AMS Diagnostics, LLC

Reason for recall

Marketing the devices outside 510(k) requirements

Action taken

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.

Root cause

No Marketing Application

Status

Terminated

Product code

NJT

Quantity affected

167 kits

Distribution

Nationwide Distribution including FL, GA, MD, CA, NC, MA, SC, WY, and TX.

Date initiated

2014-02-11

Date posted

2014-03-21

Date terminated

2016-09-29

Location

Weston, FL