FDA Device recall Z-0082-2027
Sperm Ab ELISA
- FDA Device
- Class II
- ongoing
- Published 2026-10-14
On 2026-10-14 the FDA classified a Class II recall of Sperm Ab ELISA by Drg International, citing potential for false negative patient results.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0082-2027 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-07-02 |
| Published | 2026-10-14 |
| Last updated | 2026-10-21 05:30 UTC |
| Company | Drg International |
| Distribution | US |
Product
Sperm Ab ELISA; Model/Catalog Number: EIA-1826; Product Description: Sperm Ab ELISA (96 well plate test);
Reason
Potential for false negative patient results.
Identifiers
| code_info | Model/Catalog Number: EIA-1826; UDI: 04048474018264; Lot# 320K046; |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-10-21 05:30 UTC. Current status: ongoing.
Other recalls by Drg International
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FDA Device · Class III · 2025-08-13 · Drg International - DRG:HYBRiD-XL Insulin
FDA Device · Class II · 2025-01-22 · Drg International - 17-OH Progesterone ELISA 96 well kit- An enzyme immunoassay for the quantitative in vitro diagnostic measurement of 17-OH Progesterone (17-…
FDA Device · Class III · 2024-11-06 · Drg International - Product Name: Salivary Testosterone ELISA Model/Catalog Number: SLV-3013 Product Description: An enzyme immunoassay for the quantitative in…
FDA Device · Class III · 2024-08-21 · Drg International - C-Peptide ELISA : IVD measurement of C-Peptide in serum, plasma (EDTA-, heparin- or citrate plasma) and urine
FDA Device · Class II · 2022-04-13 · Drg International
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0082-2027%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.