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Proteus OX19 Agglutinating Serum

REMEL EUROPE LIMITED · Model R30165801 · UDI-DI 05056080501604

GSY
0
510(k) clearances
0
Adverse events
2
Recalls
2
Facilities

Recalls

DateFirmReason
2004-10-20BD Diagnostic SystemsFebrile Antigens and Control Antisera that were released prior to August 2003 contained the 12/2000 revised insert that had incorrect testing instructions.
2004-10-20BD Diagnostic SystemsFebrile 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.