Class III — Low Risk

Low risk — use of or exposure to this product is not likely to cause adverse health consequences.

17-OH Progesterone ELISA 96 well kit- An enzyme immunoassay for Recalled by DRG International, Inc. Due to The High and Low Control acceptance ranges in...

Date: September 13, 2024
Company: DRG International, Inc.
Status: Ongoing
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact DRG International, Inc. directly.

Affected Products

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

Quantity: 504 units

Why Was This 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.

Where Was This Sold?

This product was distributed to 3 states: AZ, CA, NH

Affected (3 states)Not affected

About DRG International, Inc.

DRG International, Inc. has 6 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report