Product Name: Salivary Testosterone ELISA Model/Catalog Number: SLV-3013 Product Description: An enzyme immunoassay fo
Summary
The FDA issued a Class III for Product Name: Salivary Testosterone ELISA Model/Catalog Number: SLV-3013 Produ by DRG International, Inc.. Reason: Invalid Controls. The Low Control is out of range; too high which causes invalid runs that would result in repeating the runs and delays for reportin.
Details
Source
Device Recall
External ID
Z-2622-2024
Action Date
2024-08-21
Status
Ongoing
Category
device
Product Description
Product Name: Salivary Testosterone ELISA Model/Catalog Number: SLV-3013 Product Description: An enzyme immunoassay for the quantitative in vitro diagnostic measurement of free active testosterone in saliva.
Lot/Code Info: Model/Catalog Number: SLV-3013; UDI-DI: 04048474030136; Lot Nymbers: 66K014 and 66K123.
Quantity Affected: 257 units
Reason for Recall
Invalid Controls. The Low Control is out of range; too high which causes invalid runs that would result in repeating the runs and delays for reporting results to patients.
Distribution
US Nationwide distribution in the states of CA, IL, MN, PA, UT, VA.
Type: Voluntary: Firm initiated
Recall Initiated: 2024-07-05
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 202 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-2622-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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