CLASS II Device recall · Reported 28 Nov 2018 · FDA Enforcement Report

Kit Urin Cup Plc 0 Ua Yel recalled by Becton Dickinson &

Becton Dickinson & is recalling Kit Urin Cup Plc 0 Ua Yel, distributed in Illinois. The recall was initiated on 30 Aug 2018 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesAll lots within expiry

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

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0493-2019
FDA event ID: 81148
Recalling firm: Becton Dickinson &, Franklin Lakes, NJ
Classification: Class II
Status: Terminated
Recall initiated: 30 Aug 2018
FDA classified: 21 Nov 2018
Reported: 28 Nov 2018
Type: Voluntary: Firm initiated
Customers notified by: E-Mail
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

30 Aug 2018	Recall initiated by company
21 Nov 2018	Classified by FDA	+83 days
28 Nov 2018	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Product as listed by the FDA

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

Where it was distributed

Illinois

Questions about this recall

Is Kit Urin Cup Plc 0 Ua Yel recalled?

Yes. Becton Dickinson & recalled Kit Urin Cup Plc 0 Ua Yel on 30 Aug 2018. The recall is Class II and its status is Terminated. Recall number Z-0493-2019.

Why was it recalled?

Which lots are affected?

All lots within expiry

Where was it sold?

Illinois

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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