Recall Z-0491-2019 ยท JTW System, Transport, Aerobic
Becton Dickinson & Company
BD Vacutainer Urine Collection Cups, Cat. No. 364941
| Date | Aug 30, 2018 |
| Status | Terminated |
| 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. |
| Root cause | Under Investigation by firm |
| Action | On August 30, 2018, BD notified Sysmex via an emailed Urgent Medical Device Product Safety Alert letter. Sysmex was informed that BD had confirmed the product issue with BD Vacutainer Urine Collection Cups were used with Sysmex UF Series Analyzers. Sysmex was instructed to take the following actions: - Notify Sysmex customers of the potential for elevation of RBC counts - Complete the customer Resopnse form and email it to BD at Gail_Griffiths@bd.com to confirm receipt of the Safety Alert. Product will continue to ship so as to not impact critical patient care. BD recommends following Good |
| Quantity | Total: 29,982,150 BD cups (US); 97,800,900 BD cups (OUS) |
| Distribution | Illinois |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K790366 | URINE CULTURE KIT Bd Becton Dickinson Vacutainer Systems Preanalytic, Apr 4, 1979 |