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West Nile Virus IgM Capture DxSelect™ IgM Cutoff Calibrator (0.3 mL)
DIASORIN MOLECULAR LLC · Model EL0303 · UDI-DI 10816101022288
NOP
Prescription
1
510(k) clearances
5
Adverse events (2 deaths)
2
Recalls
9
Facilities
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2012-10-03 | Focus Diagnostics Inc | The firm recalled due to higher reactivity with some samples in the effected lots, which may reflect a higher false positive rate. |
| 2008-10-08 | Inverness Medical | It has come to our attention that users of these product lots may experience an elevation in the rate of false positivity when compared with previous product lots. Internal qualit |
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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.