Recall notification -BD Vacutainer® Urine Collection Cups

Aug 29, 2018

BD has confirmed that a small number of BD Vacutainer® Urine Collection Cups may contribute to a slight elevation of Red Blood Cell (RBC) counts when used in conjunction with the Sysmex UF Series Analyzers. Root cause investigation is ongoing at this time and corrective actions will be implemented as appropriate upon completion of this investigation.

BD recommends following Good Clinical Practice (GCP) by performing a 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 so as not to impact critical patient care.


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