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Open, Classified

Sperm Ab ELISA; Model/Catalog Number: EIA-1826; Product Description: Sperm Ab ELISA (96 well plate test);

FDA Recall Z-0082-2027 · Posted 2026-10-02

Recalling FirmDRG International, Inc.
Recall StatusOpen, Classified
Product CodeDFQ
Date Initiated2026-07-02
Product Quantity211

Reason for Recall

Potential for false negative patient results.

Firm Action

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.

Root Cause

Reprocessing Controls

Distribution Pattern

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.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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