DRG International, Inc.: Device Recall

Recall Details

Recall Number

Z-2622-2024

Classification

Class III

Product Type

Device

Recalling Firm

DRG International, Inc.

Status

Ongoing

Date Initiated

07/05/2024

Location

Springfield, NJ, United States

Voluntary/Mandated

Voluntary: Firm initiated

Product Quantity

257 units

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.

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.

Distribution Pattern

US Nationwide distribution in the states of CA, IL, MN, PA, UT, VA.

Other Recalls by DRG International, Inc.

• Class III: Low Risk 06/04/2025
  An incoming complaint reported that the expiration date on the kit box label and Certificate of Analysis (CoA) exceeded the shelf life of the standards and control solutions in the kit by 2 months (i.e., 2026-03-31 instead of 2026-01-31). The expiration dates on the bottle labels were correct (i.e., 2026-01-31).
• Class II: Risk 10/07/2024
  The user of the assay may either face a failure message during re-calibration of the Hybrid.XL instrument using the re-calibration R1 and R2 of the device or find controls out of specification (failed Control High) which causes a delay in results.
• Class III: Low Risk 09/13/2024
  The High and Low Control acceptance ranges in the Certificate of Analysis (CofA) did not match the acceptance range information on the High and Low Control Component labels. Due to the defect, the device failed to provide results, which may result in a delay in obtaining test results and a remote chance of an adverse health risk.

View all recalls by DRG International, Inc. →