Z-0491-2019Class II

BD Vacutainer Urine Collection Cups, Cat. No. 364941

Name: Z-0491-2019 BD Vacutainer Urine Collection Cups, Cat. No. 364941
Creator: Becton Dickinson & Company
Published: 2018-08-30
License: https://open.fda.gov/license/

Becton Dickinson & Co / initiated 2018-08-30 / Terminated

FDA source

Becton Dickinson & Company began a recall of BD Vacutainer Urine Collection Cups, Cat. No. 364941 on 2018-08-30. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0491-2019
Classification: Class II
Status: Terminated
Initiated: 2018-08-30
Posted: 2018-11-21
Terminated: 2020-10-21
Recalling firm: Becton Dickinson & Co
Product: BD Vacutainer Urine Collection Cups, Cat. No. 364941
Product code: JTW System, Transport, Aerobic
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.
FDA root cause: Under Investigation by firm
Action: On August 30, 2018, BD notified Sysmex via an emailed Urgent Medical Device Product Safety Alert letter. Sysmex was informed that BD had confirmed the product issue with BD Vacutainer Urine Collection Cups were used with Sysmex UF Series Analyzers. Sysmex was instructed to take the following actions: - Notify Sysmex customers of the potential for elevation of RBC counts - Complete the customer Resopnse form and email it to BD at [email protected] to confirm receipt of the Safety Alert. Product will continue to ship so as to not impact critical patient care. BD recommends following Good Clinical Practice (GCP) by performing microscopy to confirm an elevated RBC Count in a urine sample as per CLSI GP16-3A.29(4) and CAP Checklist on Urinalysis.
Quantity in commerce: Total: 29,982,150 BD cups (US); 97,800,900 BD cups (OUS)
Distribution: Illinois
Product codes and lots: All lots within expiry

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0491-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0491-2019	Class II	Terminated	Voluntary: Firm initiated	2018-11-28	2018-11-21
Z-0492-2019	Class II	Terminated	Voluntary: Firm initiated	2018-11-28	2018-11-21
Z-0493-2019	Class II	Terminated	Voluntary: Firm initiated	2018-11-28	2018-11-21
Z-0494-2019	Class II	Terminated	Voluntary: Firm initiated	2018-11-28	2018-11-21

Product code JTW

K790366Class IUrine Culture KitBd Becton Dickinson Vacutainer Systems Preanalytic / cleared 1979-04-04

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)