Medical Device Recall: Product Name: Salivary Testosterone ELISA Model/Catalog Number: SLV-3013 Product Description: An enzyme immunoassay for the quantitative in vitro diagnostic measurement of free active testosterone i
DRG International, Inc. · July 5, 2024
Reason for Recall
Invalid Controls. The Low Control is out of range; too high which causes invalid runs that would result in repeating the runs and delays for reporting results to patients.
Product Description
Product Name: Salivary Testosterone ELISA Model/Catalog Number: SLV-3013 Product Description: An enzyme immunoassay for the quantitative in vitro diagnostic measurement of free active testosterone in saliva.
Distribution
US Nationwide distribution in the states of CA, IL, MN, PA, UT, VA.
States Affected
NATIONWIDE
Quantity Affected
257 units
Source: FDA (openFDA Device Enforcement)
Recall number: Z-2622-2024
Status: ongoing
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