Class 3 Device Recall FastPack IP Sex Hormone Binding Globulin Immunoassay

• Date Initiated by Firm: December 03, 2024
• Date Posted: January 03, 2025
• Recall Status: Open, Classified
• Recall Number: Z-0805-2025
• Recall Event ID: 95807
• 510(K)Number: K182521
• Product Classification: Radioimmunoassay, testosterones and dihydrotestosterone - Product Code CDZ
• Product: The FastPack IP Sex Hormone Binding Globulin Immunoassay, Part #25000081, is for the quantitative measurement of SHBG in human serum and plasma. For in vitro diagnostic Use and contains 30 FastPacks.
• Code Information: UDI-DI: 20816467020345, Lot numbers: 2408018-1 Exp: 2025-09-05; 2409015-1, Exp: 2025-06-27; and 2409015-2, Exp: 2025-06-26.
• FEI Number: 3003355251
• Recalling Firm/ Manufacturer: Qualigen Inc; 2042 Corte Del Nogal; Ste B; Carlsbad CA 92011-1438
• For Additional Information Contact: Erin Hoffman; 760-5796900 Ext. 267
• Manufacturer Reason for Recall: Three lots of the FastPacks kitted into the FastPack SHBG Complete Kits were labeled with the incorrect expiration date. The following is a listing of affected lots: Lot Number: 2408018-1, 2409015-1, and 2409015-2. The likelihood of patient harm is expected to be low as routine Quality Control should detect kits that are impacted by signal deterioration due to age.
• FDA Determined Cause: Labeling Change Control
• Action: The recalling firm issued letters dated 11/19/2024 via email to their customers explaining the reason for recall and providing the correct expiration dates for each of the affected lot numbers. The risk to health was provided and instructions given to be completed. The instructions were to cease use of the affected product, dispose of all remaining kits from the affected lot numbers, document the number of kits disposed, complete the acknowledgment form by FAX or email within 5 days.
• Quantity in Commerce: 426
• Distribution: Distribution was made to AR, CA, CO, FL, IL, IN, MA, MO, NC, NY, OH, OK, TN, TX, and VA. There was no military/government/foreign distribution.
• 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