Z-0491-2019 Class II Terminated
FDA device recall Z-0491-2019 was initiated by Becton Dickinson & Company on Aug 30, 2018 and is designated Class II. 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… The recall status is terminated (terminated Oct 21, 2020). Affected quantity: Total: 29,982,150 BD cups (US); 97,800,900 BD cups (OUS).
Recall Details
- Product Type
- Devices
- Report Date
- Nov 28, 2018
- Initiation Date
- Aug 30, 2018
- Termination Date
- Oct 21, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- Total: 29,982,150 BD cups (US); 97,800,900 BD cups (OUS)
Product Description
BD Vacutainer Urine Collection Cups, Cat. No. 364941
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.
Distribution Pattern
Illinois
Code Information
All lots within expiry
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0491-2019
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 24, 2026