FDA Medical Device Recalls (openFDA)
DRG International, Inc.: 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.
- Recall number
- Z-2622-2024
- Recalling firm
- DRG International, Inc.
- 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.
- Status
- Open, Classified
- Initiated
- 2024-07-05
- Posted
- 2024-08-15
- Terminated
- not on file
- 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.
- Root cause
- Nonconforming Material/Component
- Action
- 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: qa@drg-international.com 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).
- Quantity
- 257 units
- Distribution
- US Nationwide distribution in the states of CA, IL, MN, PA, UT, VA.
- Lot, serial or model codes
- Model/Catalog Number: SLV-3013; UDI-DI: 04048474030136; Lot Nymbers: 66K014 and 66K123.
- 510(k) numbers
- ["K052649"]
- PMA numbers
- not on file
- Product code
- CDZ
- Firm FEI
- 2245285
- Firm city
- Springfield
- Firm state
- NJ
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28