17-OH Progesterone ELISA Kit (DRG) – Control Range Mismatch (2024)
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
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
Brand
DRG International, Inc.
Lot Codes / Batch Numbers
Lot Code: 04048474012927 (DRG Instruments GmbH) lots: 22K024 and 22K034
Products Sold
Lot Code: 04048474012927 (DRG Instruments GmbH) lots: 22K024 and 22K034
DRG International, Inc. is recalling 17-OH Progesterone ELISA 96 well kit- An enzyme immunoassay for the quantitative in vitro diagnostic due to 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 Co. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
AZ, CA, GA, NH
Page updated: Jan 10, 2026