DRG International, Inc. recalls 17-OH Progesterone ELISA 96 well kit- An enzyme immunoassay for the quantitative in vitro diagnostic measurement of 17-…

Recall date

September 13, 2024

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0258-2025

FDA classification

Class III

Brand / firm

DRG International, Inc.

Sold / distributed

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

Why it was recalled

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.

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

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