Recall Z-2622-2024— DRG International, Inc.
Class III · Ongoing
Class III FDA medical device recall by DRG International, Inc., initiated 2024-07-05. It names one FDA 510(k) clearance: K052649. Product: 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: 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..
- Recalling firm
- DRG International, Inc.
- Classification
- Class III
- Status
- Ongoing
- Initiated
- 2024-07-05
- Firm location
- Springfield, NJ, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.