Recall Z-0805-2025 ยท CDZ Radioimmunoassay, Testosterones And Dihydrotestosterone
Qualigen Inc
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.
| Date | Jan 3, 2025 (initiated Dec 3, 2024) |
| Status | Open, Classified |
| Reason | 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. |
| Root 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 | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K182521 | FastPack IP Sex Hormone Binding Globulin Immunoassay Qualigen, Inc., Jan 29, 2019 |