FDA Device recall Z-0493-2019
KIT URIN CUP PLC 16X100 10.0 UA YEL, Cat
- FDA Device
- Class II
- terminated
- Published 2018-11-28
On 2018-11-28 the FDA classified a Class II recall of KIT URIN CUP PLC 16X100 10.0 UA YEL, Cat by Becton Dickinson And, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0493-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-08-30 |
| Published | 2018-11-28 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Becton Dickinson And |
| Distribution | IL |
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.
Identifiers
| code_info | All lots within expiry |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0493-2019%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.