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.
Qualigen
8 recalls • • Categories: Diagnostic Equipment, Other Medical Devices, Infusion Pumps
Class I - Dangerous
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.
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.
Class I - Dangerous
Specific lots have been reported to produce falsely lower than expected results for Vitamin D
Qualigen initiated this recall because the FastPack kit may cause lower than expected results due to a manufacturing defect.
Qualigen initiated this recall because the FastPack kit may cause lower than expected results due to a manufacturing defect.
Qualigen initiated this recall because the FastPack kit may cause lower than expected results due to a manufacturing defect.
Qualigen initiated this recall because the FastPack kit may cause lower than expected results due to a manufacturing defect.