Z-0493-2019 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- November 28, 2018
- Initiation Date
- August 30, 2018
- Termination Date
- October 21, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- Total: 29,982,150 BD cups (US); 97,800,900 BD cups (OUS)
Product Description
KIT URIN CUP PLC 16X100 10.0 UA YEL, Cat. No. 364981: Urine Collection Kit for collection and transport of urine specimens for urinalysis
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.
Distribution Pattern
Illinois
Code Information
All lots within expiry