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Bordetella pertussis Agglutinating Serum

REMEL EUROPE LIMITED · Model R30165501 · UDI-DI 05056080501826

GOY
1
510(k) clearances
1
Adverse events
1
Recalls
3
Facilities

Recalls

DateFirmReason
2020-07-23Remel Europe Ltd.Thermo Scientific" Remel" Bordetella pertussis Agglutinating Serum (R30165501/ZM10) is not performing, resulting in the potential for false negative results for serotypes 1 and 3

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Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

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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.