Class 3 Device Recall Salivary Testosterone ELISA

• Date Initiated by Firm: July 05, 2024
• Date Posted: August 15, 2024
• Recall Status: Open, Classified
• Recall Number: Z-2622-2024
• Recall Event ID: 95021
• 510(K)Number: K052649
• Product Classification: Radioimmunoassay, testosterones and dihydrotestosterone - Product Code CDZ
• Product: Product Name: Salivary Testosterone ELISA Model/Catalog Number: SLV-3013 Product Description: An enzyme immunoassay for the quantitative in vitro diagnostic measurement of free active testosterone in saliva.
• Code Information: Model/Catalog Number: SLV-3013; UDI-DI: 04048474030136; Lot Nymbers: 66K014 and 66K123.
• FEI Number: 2245285
• Recalling Firm/ Manufacturer: DRG International, Inc.; 841 Mountain Ave; Springfield NJ 07081-3437
• For Additional Information Contact: DRG QA Team; 973-564-7555
• Manufacturer Reason for Recall: Invalid Controls. The Low Control is out of range; too high which causes invalid runs that would result in repeating the runs and delays for reporting results to patients.
• FDA Determined Cause: Nonconforming Material/Component
• Action: On July 8, 2024 Urgent Field Safety Notification letters were sent to customers. Action to be taken by Distributors and End-users: Please check your inventory for the respective lots 66K014 and 66K123. and stop using these kits immediately and promptly quarantine them. If you faced this issue of failed controls, kindly report with daya, and request a replacement for the kits used that were affected. Also, all unused kits still in your stock of the affected lot(s) will also be replaced. Immediately reply to email: qa@drg-international.com to confirm this notice and your compliance. Please indicate in the email the quantity of kits used which failed and quantity of stock remaining. We sincerely apologize for the inconvenience this may have caused you and/or your customer(s).
• Quantity in Commerce: 257 units
• Distribution: US Nationwide distribution in the states of CA, IL, MN, PA, UT, VA.
• Total Product Life Cycle: TPLC 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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = CDZ