Z-2622-2024Class III

Product Name: Salivary Testosterone ELISA Model/Catalog Number: SLV-3013 Product Description: An enzyme...

Name: Z-2622-2024 Product Name: Salivary Testosterone ELISA Model/Catalog Number: SLV-3013 Product Description: An enzyme...
Creator: DRG International, Inc.
Published: 2024-07-05
License: https://open.fda.gov/license/

DRG International, Inc. / initiated 2024-07-05 / Open, Classified / root cause: manufacturing process

FDA source

DRG International, Inc. began a recall of Product Name: Salivary Testosterone ELISA Model/Catalog Number: SLV-3013 Product Description: An enzyme immunoassay for the quantitative in vitro diagnostic... on 2024-07-05. FDA classified it as Class III and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2622-2024
Classification: Class III
Status: Open, Classified
Initiated: 2024-07-05
Posted: 2024-08-15
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.
Product code: CDZ Radioimmunoassay, Testosterones And Dihydrotestosterone
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.
Root cause tag: manufacturing process
FDA 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: [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).
Quantity in commerce: 257 units
Distribution: US Nationwide distribution in the states of CA, IL, MN, PA, UT, VA.
Product codes and lots: Model/Catalog Number: SLV-3013; UDI-DI: 04048474030136; Lot Nymbers: 66K014 and 66K123.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2622-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2622-2024	Class III	Ongoing	Voluntary: Firm initiated	2024-08-21	2024-08-15

Product code CDZ

K052649Class IDrg Slv Testosterone Elisa TestDrg Intl., Inc. / cleared 2006-01-27

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)