Sperm Ab ELISA; Model/Catalog Number: EIA-1826; Product Description: Sperm Ab ELISA (96 well plate test);
Summary
The FDA issued a Class II for Sperm Ab ELISA; Model/Catalog Number: EIA-1826; Product Description: Sperm Ab by DRG International, Inc.. Reason: Potential for false negative patient results..
Details
Source
Device Recall
External ID
Z-0082-2027
Action Date
2026-10-14
Status
Ongoing
Category
device
Product Description
Sperm Ab ELISA; Model/Catalog Number: EIA-1826; Product Description: Sperm Ab ELISA (96 well plate test);
Lot/Code Info: Model/Catalog Number: EIA-1826; UDI: 04048474018264; Lot# 320K046;
Quantity Affected: 211
Reason for Recall
Potential for false negative patient results.
Distribution
Worldwide - US Nationwide distribution in the state of NJ and the countries of Azerbaijan, Belgium, Czech Republic, Germany, Hungary, India, Italy, Kuwait, Russia, Spain, Ukraine.
Type: Voluntary: Firm initiated
Recall Initiated: 2026-07-02
Company
Springfield, NJ
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 220 device recalls issued in the same week, part of 502 device-related FDA actions this month.
DRG International, Inc. has 7 FDA actions in our database, including 7 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
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 7 FDA actions in our database, including 7 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0082-2027" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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