FDA-Device2018-11-28Class II
KIT URIN CUP 16X100 8.0 CONI UA YEL, Cat. No. 364989 BD Vacutainer Urine Cup Kit with UA Tube for Midstream Specimens
Becton Dickinson & Company
Hazard
BD Vacutainer Urine Collection Cups may contribute to a slight elevation of Red Blood Cell (RBC) counts when used with the Sysmex UF Series Analyzers. BD recommends following Good Clinical Practice (GCP) by using microscopy to confirm an elevated RBC Count in a Urine sample as per CLSI GP16-3A. 29(4) and CAP Checklist on Urinalysis. Product will continue to ship to not impact critical patient care.
Sold states
Illinois
Affected count
Total: 29,982,150 BD cups (US); 97,800,900 BD cups (OUS)
Manufactured in
1 Becton Dr, N/A, Franklin Lakes, NJ, United States
Products
KIT URIN CUP 16X100 8.0 CONI UA YEL, Cat. No. 364989 BD Vacutainer Urine Cup Kit with UA Tube for Midstream Specimens
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0494-2019Don't want to check this manually?
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