Product Name: Salivary Testosterone ELISA recallZ-2622-2024 · DRG International, Inc. · initiated Jul 5, 2024
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from DRG International, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
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.
FDA root cause category: Nonconforming Material/Component
What the company is doing
On July 8, 2024 Urgent Field Safety Notification letters were sent to customers. Action to be taken by Distributors and End-users: Please check your inventory for the respective lots 66K014 and 66K123. and stop using these kits immediately and promptly quarantine them. If you faced this issue of failed controls, kindly report with daya, and request a replacement for the kits used that were affected. Also, all unused kits still in your stock of the affected lot(s) will also be replaced. Immediately reply to email: [email protected] to confirm this notice and your compliance. Please indicate in the email the quantity of kits used which failed and quantity of stock remaining. We sincerely apologize for the inconvenience this may have caused you and/or your customer(s).
Recall details
- Recall number
- Z-2622-2024
- Status
- Open, Classified
- Initiated by the company
- Jul 5, 2024
- Posted by the FDA
- Aug 15, 2024
- Recalling firm
- DRG International, Inc.
- Quantity
- 257 units
- Product code
- CDZ
- FDA submissions
- K052649
- Distribution
- US Nationwide distribution in the states of CA, IL, MN, PA, UT, VA.
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.
Code information (models, lots, serial numbers)
Model/Catalog Number: SLV-3013; UDI-DI: 04048474030136; Lot Nymbers: 66K014 and 66K123.
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Salivary Testosterone ELISA SLV-3013DRG Instruments Gesellschaft mit beschränkter Haftung · Radioimmunoassay, Testosterones And Dihydrotestosterone1 recall0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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