Device product

BD Vacutainer Lithium HeparinN (LH) 95 USP Units Blood Collection Tubes, Catalog Number 367886

Z-2300-2019

June 12, 2019

Class II

Product summary

Firm: Becton Dickinson & Company
Event: Event 82963
Status: Terminated
Classification: Class II
Quantity: 1,436,228,004 total
Official record key: device-enforcement:Z-2300-2019

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)30382903678861

Distribution pattern: Worldwide Distribution, including US Nationwide

Derived failure modes

Unknown
reason.no_named_rule · v1.0.0

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.