Qualigen Inc. has recalled 426 units of the FastPack IP Sex Hormone Binding Globulin (SHBG) Immunoassay (Part #25000081) because three lots were labeled with incorrect expiration dates. These kits are used in medical laboratories and healthcare settings to measure SHBG levels in human blood samples. While the company believes the risk of harm is low because standard laboratory quality checks should catch any performance issues, using the kits beyond their true shelf life could potentially impact testing accuracy. No incidents or injuries have been reported.
The incorrect labels could lead laboratories to use testing components after they have degraded. Although routine quality control processes are expected to identify aged kits, using a product past its actual expiration date could result in incorrect diagnostic measurements.
Manufacturer correction/replacement
Used for the quantitative measurement of SHBG in human serum and plasma for in vitro diagnostic use.
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
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Sources: FDA iRES · Raw API Response
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