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WONDFO USA CO., LTD. · Model PRE-PDOA-9135A3 · UDI-DI 00816862021783
10
510(k) clearances
8
Adverse events
2
Recalls
48
Facilities
Description
13 Panel Preview Cup: AMP-500, BAR, BUP, BZO, COC-150, MDMA, MAMP/MET-500, MTD, MOP, OXY, PCP, PPX, TCA
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-06-26 | Siemens Healthcare Diagnostics, Inc. | out-of-specification sodium azide concentration in Syva Emit Tox Serum Tricyclic Antidepressant Calibrator/Controls Lot U2. While the assay results were not impacted, the overall h |
| 2003-11-17 | Abbott Health Products, Inc. | Drug product cross reacts with the Tricyclic Antidepressants (TCA) assay. |
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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.