BD Vacut: Urine collection cups may cause slight red blood cell elevation when used with Sysmex analyzers. Follow GCP guidelines for urine testing to ensure accurate results.
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.
BD Vacutainer Urine Collection Cups (Cat. No. 364941) may cause a slight increase in red blood cell counts when used with certain lab analyzers. This could lead to inaccurate test results if not properly checked with microscopy.
The cups may cause a slight elevation in red blood cell counts when processed by Sysmex UF Series Analyzers. This could lead to inaccurate test results if not confirmed with microscopic examination as per clinical guidelines.
Lab technicians and healthcare providers who use BD Vacutainer Urine Collection Cups with Sysmex UF Series Analyzers. Patients receiving urine tests are at low risk if the cups are used correctly.
Check for BD Vacutainer Urine Collection Cups with model number 364941. All lots within their expiration date are affected.
Use microscopy to verify elevated red blood cell counts in urine samples as per CLSI GP16-3A guidelines.
No, the cups continue to ship and are not recalled for immediate safety risks. They may cause slight RBC elevation with Sysmex analyzers.
Use microscopic examination to confirm elevated red blood cell counts as per CLSI GP16-3A guidelines.
Patients are at low risk if the cups are used correctly and results are verified with microscopy.
We’ve drafted a message you can send Becton Dickinson to request your refund or repair — edit it as you like.
Subject: Recall Z-0491-2019 — Becton Dickinson Becton Dickinson Hello, I own a Becton Dickinson that is covered by recall Z-0491-2019 from Becton Dickinson. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
