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Becton Dickinson & Company recalls BD Vacutainer Specimen Collection Cups, Cat. No. 364975
Recalled November 28, 2018 · FDA recall Z-0492-2019 · Becton Dickinson &
Hazard
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. · FDA Class II
Units
Total: 29,982,150 BD cups (US); 97,800,900 BD cups (OUS)
Sold at
Illinois
Description
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.
Product
BD Vacutainer Specimen Collection Cups, Cat. No. 364975
Manufacturer(s)
Becton Dickinson & Company
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →