Recall Z-0082-2027 ยท DFQ Sperm, Antigen, Antiserum, Control
DRG International, Inc.
Sperm Ab ELISA; Model/Catalog Number: EIA-1826; Product Description: Sperm Ab ELISA (96 well plate test);
| Date | Oct 2, 2026 (initiated Jul 2, 2026) |
| Status | Open, Classified |
| Reason | Potential for false negative patient results. |
| Root cause | Reprocessing Controls |
| 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. |
| Quantity | 211 |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.