—#167547

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

FDA product code: JTW — System, Transport, Aerobic
Device class: Class 1
Medical specialty: Microbiology
Affected lot / code info: All lots within expiry

Why it was recalled

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 (FDA determination)

Under Investigation by firm

Action the firm took

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 Clinical Practice (GCP) by performing microscopy to confirm an elevated RBC Count in a urine sample as per CLSI GP16-3A.29(4) and CAP Checklist on Urinalysis.

Recalling firm

Firm: Becton Dickinson & Company
Address: 1 Becton Dr, Franklin Lakes, New Jersey 07417-1815

Distribution

Distribution pattern: Illinois

Timeline

Recall initiated: 2018-08-30
Terminated: 2020-10-21
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #167547. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.