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Trinity Biotech
MARDX DIAGNOSTICS, INC. · Model 30-7109 · UDI-DI 05391516747837
10
510(k) clearances
0
Adverse events
3
Recalls
10
Facilities
Description
Legionella Omni 18 Well Slides, 10 each pack
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2017-02-15 | Focus Diagnostics Inc | After a submission for CLIA database update from Focus Diagnostics to DiaSorin Molecular,the company found that their Legionella IFA device (IF0950) is not 510(k) exempt. |
| 2017-02-15 | Focus Diagnostics Inc | After a submission for CLIA database update from Focus Diagnostics to DiaSorin Molecular,the company found that their Legionella IFA device (IF0950) is not 510(k) exempt. |
| 2004-12-23 | Diamedix Corporation | The kits belonging to lot #s 30804/30804Z and 91803Z may lose activity, after one or two usages, causing the OD values for the Cut-Off Calibrator and/or Positive Control to be reco |
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