FDAJuly 7, 2017device
Qualigen(R) The FastPack(R) IP Vitamin D Complete Immunoassay Kit, catalog number 25000068 Vitamin D immunoassay kit
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Specific lots have been reported to produce falsely lower than expected results for Vitamin D
What to do
FDA enforcement status: Terminated
Brands named
qualigen
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- FDAThe 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.2024-12-03
- FDAFastPack TSH Calibrator Kit, REF: 25000024, For use in conjunction with the FastPack IP TSH Immunoassay and FastPack IP System Analyzer2024-08-26
- FDAThe 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 f...2019-11-06
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