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HARDY DIAGNOSTICS · Model 295101 · UDI-DI 00816576022656

GNB Prescription
10
510(k) clearances
1
Adverse events
3
Recalls
7
Facilities

Description

Shigella boydii type 10 antisera, 2ml

Recalls

DateFirmReason
2017-12-08Remel IncThe serum may fail to agglutinate within the specified minimum reaction time.
2007-11-30Becton Dickinson & Co.In vitro diagnostic test reagent for identification of Shigella bacteria in patient samples may cause false negative results.
2007-11-30Becton Dickinson & Co.In vitro diagnostic test reagent for identification of Shigella bacteria in patient samples may cause false negative results.

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Data 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.