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U.S. Department of Health and Human Services

Class 2 Device Recall BD Vacutainer Specimen Collection Cups

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  Class 2 Device Recall BD Vacutainer Specimen Collection Cups see related information
Date Initiated by Firm August 30, 2018
Create Date November 21, 2018
Recall Status1 Terminated 3 on October 21, 2020
Recall Number Z-0492-2019
Recall Event ID 81148
Product Classification System, transport, aerobic - Product Code JTW
Product BD Vacutainer Specimen Collection Cups, Cat. No. 364975
Code Information All lots within expiry
Recalling Firm/
Manufacturer		 Becton Dickinson & Company
1 Becton Dr
Franklin Lakes NJ 07417-1815
For Additional Information Contact Customer service
410-316-4050
Manufacturer Reason
for Recall		 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 Determined
Cause 2		 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 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.
Quantity in Commerce Total: 29,982,150 BD cups (US); 97,800,900 BD cups (OUS)
Distribution Illinois
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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