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U.S. Department of Health and Human Services

Class 3 Device Recall 17OH Progesterone ELISA

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 Class 3 Device Recall 17OH Progesterone ELISAsee related information
Date Initiated by FirmSeptember 13, 2024
Date PostedOctober 29, 2024
Recall Status1 Open3, Classified
Recall NumberZ-0258-2025
Recall Event ID 95429
Product Classification Radioimmunoassay, 17-hydroxyprogesterone - Product Code JLX
Product17-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
Code Information Lot Code: 04048474012927 (DRG Instruments GmbH) lots: 22K024 and 22K034
FEI Number 2245285
Recalling Firm/
Manufacturer		 DRG International, Inc.
841 Mountain Ave
Springfield NJ 07081-3437
For Additional Information ContactSAME
862-227-2316
Manufacturer 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.
FDA Determined
Cause 2		Process change control
ActionDRG 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.
Quantity in Commerce504 units
DistributionAZ, CA, NH Foreign: Austria Belgium Georgia Germany Greece India Irak Italy Netherlands Poland Romania Russia Singapore Spain Tunesia Vietnam
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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