17-OH Progesterone ELISA 96 well kit- An enzyme immunoassay for the quantitative in vitro diagnostic measurement of 17-O

FDA device recall Z-0258-2025 · posted 2024-10-29 · Open, Classified

Recall details

Recalling firm

DRG International, Inc.

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.

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.

Root cause

Process change control

Status

Open, Classified

Product code

JLX

Quantity affected

504 units

Distribution

AZ, CA, NH Foreign: Austria Belgium Georgia Germany Greece India Irak Italy Netherlands Poland Romania Russia Singapore Spain Tunesia Vietnam

Date initiated

2024-09-13

Date posted

2024-10-29

Location

Springfield, NJ