17-OH Progesterone ELISA 96 well kit- An enzyme immunoassay for the quantitative in vitro diagnostic measurement of 17-OH Progesterone (17-OHP) in serum or plasma Model/Catalog Number: EIA-1292
- Company
- Drg International, Inc.
- Recall Initiated
- September 13, 2024
- Posted
- October 29, 2024
- Recall Number
- Z-0258-2025
- Quantity
- 504 units
- Firm Location
- Springfield, NJ
Reason for Recall
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.
Distribution
AZ, CA, NH Foreign: Austria Belgium Georgia Germany Greece India Irak Italy Netherlands Poland Romania Russia Singapore Spain Tunesia Vietnam
Lot / Code Info
Lot Code: 04048474012927 (DRG Instruments GmbH) lots: 22K024 and 22K034
Root Cause
Process change control
Action Taken
DRG issued Urgent Field Safety Notification on 9/17/24 via email. Letter states reason for recall, health risk and action to take: Please check your inventory for the respective lot and ensure that the proper acceptance ranges provided below are used to validate the assay. Immediately reply to email: qa@drg-international.com to confirm this notice and your compliance.