Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

AMS URIC ACID For the In vitro quantitative determination of Uric Acid in serum Quantitative determination of Uric Acid in serum.

FDA Recall Z-1268-2014 · Posted 2014-03-21

Recalling FirmAMS Diagnostics, LLC
Recall StatusTerminated
Product CodeNJT
Date Initiated2014-02-11
Date Terminated2016-09-29
Product Quantity13 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.

↑