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EZ-SHIGELLA One-Step Shigella species Rapid Test
BIOMERICA, INC. · Model 1009-15 · UDI-DI 00083059100952
10
510(k) clearances
1
Adverse events
3
Recalls
7
Facilities
Description
The Biomerica Shigella species test is a lateral flow immunoassay for the rapid determination of the presence of Shigella species in human stool samples. The test is intended for professional use only.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2017-12-08 | Remel Inc | The serum may fail to agglutinate within the specified minimum reaction time. |
| 2007-11-30 | Becton Dickinson & Co. | In vitro diagnostic test reagent for identification of Shigella bacteria in patient samples may cause false negative results. |
| 2007-11-30 | Becton Dickinson & Co. | In vitro diagnostic test reagent for identification of Shigella bacteria in patient samples may cause false negative results. |
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