BD Vacutainer Urine Collection Cups recall
BD Vacutainer Urine Collection Cups, Cat. No. 364941
Why was BD Vacutainer Urine Collection Cups recalled?
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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
All lots within expiry
- Product
- BD Vacutainer Urine Collection Cups, Cat. No. 364941
- Recalling firm
- Becton Dickinson & Company
- Quantity
- Total: 29,982,150 BD cups (US); 97,800,900 BD cups (OUS)
- Distribution
- Illinois
- Recall date
- November 28, 2018
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)