Becton Dickinson & Company: Medical Device Recall in 2018 - (Recall #: Z-0494-2019)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: August 30, 2018

Date Posted: November 28, 2018

Recall Number: Z-0494-2019

Event ID: 81148

Reason for Recall:

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.

Status: Terminated

Product Quantity: Total: 29,982,150 BD cups (US); 97,800,900 BD cups (OUS)

Code Information:

All lots within expiry

Distribution Pattern:

Illinois

Voluntary or Mandated:

Voluntary: Firm initiated