FDA (Devices) recall action 81148
The FDA (Devices) publishes a recall like this one as 4 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 4 pages.
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.
The agency’s own wording, quoted from the enforcement report.
Becton Dickinson is recalling urine collection cups that may cause slight red blood cell count elevations when used with specific analyzers.
Becton Dickinson is recalling BD Vacutainer Urine Collection Cups because they may cause slight elevations in red blood cell counts when used with specific analyzers.
Becton Dickinson is recalling BD Vacutainer Urine Cup Kits because they may cause slight red blood cell count elevations when used with specific analyzers.
Becton Dickinson is recalling BD Vacutainer Urine Collection Cups because they may cause slight elevations in red blood cell counts when used with specific analyzers.