Recall Z-0491-2019— Becton Dickinson & Company

Name: FDA recall Z-0491-2019
Creator: U.S. Food and Drug Administration
Published: 2018-08-30

Class II · Terminated

Class II FDA medical device recall by Becton Dickinson & Company, initiated 2018-08-30, terminated 2020-10-21. It names one FDA 510(k) clearance: K790366. Product: BD Vacutainer Urine Collection Cups, Cat. No. 364941. 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..

Recalling firm: Becton Dickinson & Company
Classification: Class II
Status: Terminated
Initiated: 2018-08-30
Terminated: 2020-10-21
Firm location: Franklin Lakes, NJ, United States

510(k) clearances named in this recall

1 on FDA's record

K790366 — URINE CULTURE KITBd Becton Dickinson Vacutainer Systems Preanalytic·cleared 1979-04-04

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

BD Vacutainer Urine Collection Cups, Cat. No. 364941

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.