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GenaCheck Vaginal pH Screening Test
Genabio Diagnostics Inc. · Model RA9-E02303 · UDI-DI 00810143620016
4
510(k) clearances
5
Adverse events
2
Recalls
31
Facilities
Recalls
| Date | Firm | Reason |
|---|---|---|
| 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 |
| 2003-08-28 | Instrumentation Laboratory Co. | Lactate Disposable Membrane Caps linearity was determined to be significantly biased and could potentially cause erroneous patient results above 6.0 mmol/L. |
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