17-OH Progesterone ELISA 96 well kit- An enzyme immunoassay for the quantitative in vitro diagnostic measurement of 17-O
Summary
The FDA issued a Class III for 17-OH Progesterone ELISA 96 well kit- An enzyme immunoassay for the quantitative by DRG International, Inc.. Reason: 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.
Details
Source
Device Recall
External ID
Z-0258-2025
Action Date
2024-11-06
Status
Ongoing
Category
device
Product Description
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
Lot/Code Info: Lot Code: 04048474012927 (DRG Instruments GmbH) lots: 22K024 and 22K034
Quantity Affected: 504 units
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.
Distribution
AZ, CA, NH Foreign: Austria Belgium Georgia Germany Greece India Irak Italy Netherlands Poland Romania Russia Singapore Spain Tunesia Vietnam
Type: Voluntary: Firm initiated
Recall Initiated: 2024-09-13
Company
Springfield, NJ
Context & Analysis
This is a Class III recall. Class III recalls involve products unlikely to cause adverse health consequences, but that violate FDA regulations.
This was one of 243 device recalls issued in the same week, part of 403 device-related FDA actions this month.
DRG International, Inc. has 6 FDA actions in our database, including 6 recalls.
Frequently Asked Questions
What is a Class III recall?
A Class III recall involves products that are unlikely to cause adverse health effects but violate FDA labeling or manufacturing regulations.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (DRG International, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does DRG International, Inc. have FDA actions?
DRG International, Inc. has 6 FDA actions in our database, including 6 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0258-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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