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Shigella Antisera Set 2
MAST GROUP LIMITED · Model M10105 · UDI-DI 15060392378035
GNB
Prescription
10
510(k) clearances
1
Adverse events
3
Recalls
7
Facilities
Description
Shigella Antisera Set 2 - A set containing 8 polyvalent and 11 monovalent antisera for serotyping Shigella, dysenteriae, Shigella flexneri, Shigella boydii and Shigella sonnei strains
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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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.