Recall Z-0493-2019— Becton Dickinson & Company
Class II · Terminated
Class II FDA medical device recall by Becton Dickinson & Company, initiated 2018-08-30, terminated 2020-10-21. FDA's recall record names no specific 510(k) clearance for this event. Product: 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: 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..
- Recalling firm
- Becton Dickinson & Company
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2018-08-30
- Terminated
- 2020-10-21
- Firm location
- Franklin Lakes, NJ, United States
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.