Product Name: Salivary Testosterone ELISA Model/Catalog Number: SLV-3013 Product Description: An enzyme immunoassay for
FDA device recall Z-2622-2024 · posted 2024-08-15 · Open, Classified
Recall details
- Recalling firm
- DRG International, Inc.
- 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.
- Action taken
- 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).
- Root cause
- Nonconforming Material/Component
- Status
- Open, Classified
- Product code
- CDZ
- Quantity affected
- 257 units
- Distribution
- US Nationwide distribution in the states of CA, IL, MN, PA, UT, VA.
- Date initiated
- 2024-07-05
- Date posted
- 2024-08-15
- Location
- Springfield, NJ
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| DRG SLV TESTOSTERONE ELISA TEST (K052649) | Drg Intl., Inc. | 2006-01-27 |