FDA Class II · Medical device · October 14, 2026
Sperm Ab ELISA recall — DRG International, Inc.
Potential for false negative patient results.
Official ID Z-0082-2027 · Official record ↗
DRG International recalls
Recall found. DRG International is named in FDA Class II recall Z-0082-2027 covering Sperm Ab ELISA. Hazard: Potential for false negative patient results. Identifying details: Model/Catalog Number: EIA-1826; UDI: 04048474018264; Lot# 320K046;. Status: Ongoing.
Models with recalls
All DRG International recalls
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- Recalls.gov — the U.S. government’s all-agency portal ↗
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Compiled from official public-domain government data. Last checked October 22, 2026 at 12:00 PM UTC.