medical Class II Updated 2018-11-28

Becton Dickinson & Company recalls KIT URIN CUP 16X100 8.0 CONI UA YEL, Cat. No. 364989 BD Vac

Recalled Product

KIT URIN CUP 16X100 8.0 CONI UA YEL, Cat. No. 364989 BD Vacutainer Urine Cup Kit with UA Tube for Midstream Specimens


Hazard / Issue

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.

Issued by

FDA

Distribution: Illinois
Lot/Code Info: All lots within expiry
View official government recall

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