Sperm Ab ELISA recallZ-0082-2027 · DRG International, Inc. · initiated Jul 2, 2026
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from DRG International, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Potential for false negative patient results.
FDA root cause category: Reprocessing Controls
What the company is doing
On July 2, 2026 Field Safety Notice letters were sent to customers. Actions to be taken: Please check your stocks for the lot in question (320K046), stop using these kits immediately and quarantine these products without delay. Please destroy the kits and send us the confirmation with the completed response form. If you have transferred any of the affected products to another laboratory, please provide them with a copy of this letter.
Recall details
- Recall number
- Z-0082-2027
- Status
- Open, Classified
- Initiated by the company
- Jul 2, 2026
- Posted by the FDA
- Oct 2, 2026
- Recalling firm
- DRG International, Inc.
- Quantity
- 211
- Product code
- DFQ
- 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.
Product description
Sperm Ab ELISA; Model/Catalog Number: EIA-1826; Product Description: Sperm Ab ELISA (96 well plate test);
Code information (models, lots, serial numbers)
Model/Catalog Number: EIA-1826; UDI: 04048474018264; Lot# 320K046;
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Sperm Antibody ELISA EIA-1826DRG Instruments Gesellschaft mit beschränkter Haftung · SPERM, ANTIGEN, ANTISERUM, CONTROL1 recall0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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