The FastPack System Comlete Immunoassay Kit Immunoassay for the Quantitative Measurement of SHBG is a chemiluminescent immunoassay intended for the quantitative determination of Sex Hormone Binding Globulin in human serum and plasma on the FastPack System. The FastPack IP SHBG assay is intended for use as an aid in the diagnosis of androgen disorders. Each Kit Contains 30 FastPack IP SHBG Immunoassays 1 Calibrator 1 x 3 mL Vial 1 Control 1 1 x 3 mL Vial 1 Control 2 1 x 3 mL Vials 32 Sample Diluent 0.9 mL Vials REF 25000081 IVD CE 1908038-1P 2020-02-22 (01) 20816467020345 (17) 200222 (10) 1908038-1P
Class I - DangerousWhat Should You Do?
- Check if you have this product: 1908038-1P 2020-02-22 (01) 20816467020345 (17) 200222 (10) 1908038-1P
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Qualigen Inc
- Reason for Recall:
- The chemiluminescent immunoassay has been noted to have higher than expected results which may result in inaccurate quantitative determinations of Sex Hormone Binding Globulin in human serum and plasma.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
The FastPack System Comlete Immunoassay Kit Immunoassay for the Quantitative Measurement of SHBG is a chemiluminescent immunoassay intended for the quantitative determination of Sex Hormone Binding Globulin in human serum and plasma on the FastPack System. The FastPack IP SHBG assay is intended for use as an aid in the diagnosis of androgen disorders. Each Kit Contains 30 FastPack IP SHBG Immunoassays 1 Calibrator 1 x 3 mL Vial 1 Control 1 1 x 3 mL Vial 1 Control 2 1 x 3 mL Vials 32 Sample Diluent 0.9 mL Vials REF 25000081 IVD CE 1908038-1P 2020-02-22 (01) 20816467020345 (17) 200222 (10) 1908038-1P
Product Codes/Lot Numbers:
1908038-1P 2020-02-22 (01) 20816467020345 (17) 200222 (10) 1908038-1P
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1672-2020
Related Recalls
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.
Thyroid Stimulating Hormone (TSH) calibrator card has an incorrect barcode linked to incorrect information, that may allow successful system calibration, but the TSH results obtained could be higher than expected.
Specific lots have been reported to produce falsely lower than expected results for Vitamin D