Date Initiated by Firm |
August 30, 2018 |
Create Date |
November 21, 2018 |
Recall Status1 |
Terminated 3 on October 21, 2020 |
Recall Number |
Z-0494-2019 |
Recall Event ID |
81148 |
Product Classification |
System, transport, aerobic - Product Code JTW
|
Product |
KIT URIN CUP 16X100 8.0 CONI UA YEL, Cat. No. 364989 BD Vacutainer Urine Cup Kit with UA Tube for Midstream Specimens |
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
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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
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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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