FDA Medical devices recall ·
The FastPack IP Sex Hormone Binding Globulin Immunoassay, Part #25000081… recall
- Recall number
- Z-0805-2025
- Date
- (initiated December 3, 2024)
- Company / brand
- Qualigen Inc
2042 Corte Del Nogal, Carlsbad, CA, United States - Category
- Medical devices › Class III
- Classification
- Class III
- Status
- Ongoing
- Units affected
- 426
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
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.
Why was it recalled?
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.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
UDI-DI: 20816467020345, Lot numbers: 2408018-1 Exp: 2025-09-05; 2409015-1, Exp: 2025-06-27; and 2409015-2, Exp: 2025-06-26.
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.
States: Arkansas California Colorado Florida Illinois Indiana Massachusetts Missouri North Carolina New York Ohio Oklahoma Tennessee Texas Virginia
What does Class III mean?
Class III means use of or exposure to the product is not likely to cause adverse health consequences (for example, a labeling violation).
Source: FDA (medical devices), recall Z-0805-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.