DRG International, Inc. recalls Product Name: Salivary Testosterone ELISA Model/Catalog Number: SLV-3013 Product Description: An enzyme immunoassay for…
- Recall date
- July 5, 2024
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-2622-2024
- FDA classification
- Class III
- Brand / firm
- DRG International, Inc.
- Sold / distributed
- US Nationwide distribution in the states of CA, IL, MN, PA, UT, VA.
Why it was recalled
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.
Class III means the product violates regulations but is not likely to cause harm.
What was recalled
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.
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