FDA recall Z-2301-2019

Product

BD Vacutainer PST Gel and Lithium HeparinN (LH) 56 Units Blood Collection Tubes, Catalog Number 367960

Reason for recall

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.

Distribution

Worldwide Distribution, including US Nationwide

Key facts

Status

Terminated

Initiation date

2019-06-12

Report date

2019-08-28

Termination date

2020-06-29

Voluntary/Mandated

Voluntary: Firm initiated

Location

Franklin Lakes, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2301-2019