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SpermMar IgG Negative Control
VITROLIFE INC. · Model 15517 · UDI-DI 00805360018449
0
510(k) clearances
0
Adverse events
2
Recalls
10
Facilities
Description
SpermMar IgG Negative Control
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-07-02 | DRG International, Inc. | Potential for false negative patient results. |
| 2025-11-22 | Changchun Wancheng Bio-Electron Co., Ltd. | Test strips and other tests including for near-patient testing, that require a 510(k) were distributed before they could be legally marketed to U.S. customers; devices may cause fa |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.