FDAFDA · Food and drugs·Recall number Z-2305-2019
BD Vacutainer PST Gel and Lithium HeparinN (LH) 126 Units Blood Collection Tubes, Catalog Number 367964
Published August 28, 2019 · Recall initiated: June 12, 2019
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
False elevation of carboxyhemoglobin (COHb) results have been reported when using venous blood gas samples collected with tubes analyzed with the IL GEM 4000 instrument.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Becton Dickinson & Company
- Distributor
- Worldwide Distribution, including US Nationwide
- Lot
- UDI: (01)30382903679646
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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