Diagnostic Immunoassay Kits Recalled for Incorrect Expiration Date Labeling
Qualigen is recalling 426 units of FastPack SHBG diagnostic kits due to incorrect expiration date labels on three lots. The kits were distributed to 15 U.S. states.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: FDA Class III recall with incorrect expiration date labeling on diagnostic kits. The source explicitly states that patient harm likelihood is expected to be low, as routine quality control should detect age-related signal deterioration. No illnesses or injuries reported.
Plain-English summary
Qualigen Inc. is recalling 426 units of the FastPack IP Sex Hormone Binding Globulin (SHBG) Immunoassay kits. This in vitro diagnostic test is used to measure SHBG levels in human serum and plasma samples.
Three lots of kits were labeled with incorrect expiration dates: Lot 2408018-1, 2409015-1, and 2409015-2. Diagnostic kits can experience signal deterioration as they age, and incorrect expiration labeling could affect test accuracy and performance. However, the FDA expects the risk of patient harm to be low, as routine quality control procedures should detect kits impacted by age-related signal deterioration.
The affected kits were distributed to clinical laboratories and healthcare facilities in 15 U.S. states: Arkansas, California, Colorado, Florida, Illinois, Indiana, Massachusetts, Missouri, North Carolina, New York, Ohio, Oklahoma, Tennessee, Texas, and Virginia.
If you possess kits from any of the affected lots, review the labeling and contact Qualigen Inc. directly for guidance on next steps.
The recalled product
- 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.
- Manufacturer
- Qualigen Inc
- Hazard
- labeling-error
- assay-degradation
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (6)
- 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
Distributed in 15 states:
- AR
- CA
- CO
- FL
- IL
- IN
- MA
- MO
- NC
- NY
- OH
- OK
- TN
- TX
- VA
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