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REMEL EUROPE LIMITED · Model R30855001 · UDI-DI 05056080500065

510(k) clearances

Adverse events

Recalls

Facilities

Recalls

Date	Firm	Reason
2010-05-19	Becton Dickinson & Co.	In vitro diagnostic reagent to aid in the diagnosis of Salmonellosis may exhibit decreased or no reactivity. If proper controls are run with the lot in question, it would become ap
2004-10-20	BD Diagnostic Systems	Febrile Antigens and Control Antisera that were released prior to August 2003 contained the 12/2000 revised insert that had incorrect testing instructions.
2004-10-20	BD Diagnostic Systems	Febrile Antigens and Control Antisera that were released prior to August 2003 contained the 12/2000 revised insert that had incorrect testing instructions.
2004-10-20	BD Diagnostic Systems	Febrile Antigens and Control Antisera that were released prior to August 2003 contained the 12/2000 revised insert that had incorrect testing instructions.
2004-10-20	BD Diagnostic Systems	Febrile Antigens and Control Antisera that were released prior to August 2003 contained the 12/2000 revised insert that had incorrect testing instructions.

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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.