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.
Reported: August 21, 2024 Initiated: July 5, 2024 #Z-2622-2024
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.
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.
Details
- Recalling Firm
- DRG International, Inc.
- Units Affected
- 257 units
- Distribution
- US Nationwide distribution in the states of CA, IL, MN, PA, UT, VA.
- Location
- Springfield, NJ
Frequently Asked Questions
What product 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.. Recalled by DRG International, Inc.. Units affected: 257 units.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on August 21, 2024. Severity: Low. Recall number: Z-2622-2024.
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