Skip to content
Recall Observatory FDA recall evidence

Device product

KIT URIN CUP PLC 16X100 10.0 UA YEL, Cat. No. 364981: Urine Collection Kit for collection and transport of urine specimens for urinalysis

Z-0493-2019

August 30, 2018

Class II

Product summary

Firm
Becton Dickinson & Company
Event
Event 81148
Status
Terminated
Classification
Class II
Quantity
Total: 29,982,150 BD cups (US); 97,800,900 BD cups (OUS)
Official record key
device-enforcement:Z-0493-2019

Official wording

Reason: 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.

Code information: All lots within expiry

Distribution pattern: Illinois

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.