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PROTEUS OX2 ANTIGEN
GERMAINE LABORATORIES, INC · Model 1201 · UDI-DI 00695684012014
GSY
Prescription
0
510(k) clearances
0
Adverse events
2
Recalls
2
Facilities
Description
Proteus OX2 Antigens are intended for the detection of bacterial agglutinins associated with a bacterial infection.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 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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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.
