Device product
BD Vacutainer PST Gel and Lithium HeparinN (LH) Blood Collection Tubes, Catalog Number 367963
Z-2304-2019
Product summary
- Event
- Event 82963
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1,436,228,004 total
- Official record key
device-enforcement:Z-2304-2019
Official wording
Reason: 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.
Code information: UDI: (01)30382903679639
Distribution pattern: Worldwide Distribution, including US Nationwide
Derived failure modes
-
Unknown
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.