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
Check against the official notice below — it lists the full affected range.
Qualigen Inc has recalled The FastPack System Complete Immunoassay Kit, which is designed to measure Sex Hormone Binding Globulin levels in blood samples. The kit's chemiluminescent immunoassay has been found to produce higher than expected results, which can lead to inaccurate measurements of Sex Hormone Binding Globulin in human serum and plasma.
The recall affects 24 kits containing 30 test packs each (720 total tests) with lot code 1908038-1P and expiration date of February 22, 2020. The affected product was distributed nationwide in Alabama, Alaska, California, Hawaii, and Texas. The source document does not specify what action affected consumers should take regarding this recall.
Written by software from the official notice below. Not reviewed by a lawyer.
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.
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. Distribution: US Nationwide distribution in the states of AL, AK, CA, HI, and TX. Quantity: 24 Kits (30 test packs each) 720 tests Lot/code info: 1908038-1P 2020-02-22 (01) 20816467020345 (17) 200222 (10) 1908038-1P
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.