Becton Dickinson recalls urine cup kits that may cause slight red blood cell elevation when used with Sysmex analyzers. Follow clinical guidelines to confirm results. Product continues shipping for patient care.
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.
Becton Dickinson is recalling urine collection cups that could cause a slight increase in red blood cell counts when used with certain lab analyzers. This is a minor lab result issue that requires confirming results through microscopic examination per clinical guidelines.
The urine cups may cause a slight elevation in red blood cell counts when processed by Sysmex UF Series analyzers. This is a minor lab result discrepancy that requires microscopic confirmation per clinical guidelines to avoid misdiagnosis.
Lab technicians and healthcare providers using the urine cup kits with Sysmex UF Series analyzers. Patients are not directly affected as the issue is a lab result interpretation concern.
Look for the kit labeled 'KIT URIN CUP 16X100 8.0 CONI UA YEL' with catalog number 364989. All lots within expiration date are affected.
Use microscopic examination to verify elevated red blood cell counts as per clinical guidelines.
No, the issue is a minor lab result discrepancy that requires confirmation through microscopic examination, not a direct patient risk.
No, the product continues to be shipped and used as normal; follow clinical guidelines for result confirmation.
Check for the kit labeled 'KIT URIN CUP 16X100 8.0 CONI UA YEL' with catalog number 364989.
We’ve drafted a message you can send Becton Dickinson to request your refund or repair — edit it as you like.
Subject: Recall Z-0494-2019 — Becton Dickinson Becton Dickinson Hello, I own a Becton Dickinson that is covered by recall Z-0494-2019 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.
