FDA (Devices) recall action 82963
The FDA (Devices) publishes a recall like this one as 15 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 15 pages.
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.
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
Becton Dickinson is recalling specific blood collection tubes because they can cause false elevation of carboxyhemoglobin results when used with the IL GEM 4000 instrument.
Becton Dickinson is recalling BD Vacutainer Lithium Heparin blood collection tubes because they may cause false elevation of carboxyhemoglobin results when used with the IL GEM 4000 instrument.
Becton Dickinson is recalling BD Vacutainer LH blood collection tubes because they may cause false elevation of carboxyhemoglobin results when used with the IL GEM 4000 instrument.
Becton Dickinson is recalling BD Vacutainer PST Gel and Lithium Heparin blood collection tubes because they may cause false elevation of carboxyhemoglobin results when used with the IL GEM 4000 instrument.
Becton Dickinson is recalling specific blood collection tubes because they may cause false elevation of carboxyhemoglobin results when used with the IL GEM 4000 instrument.
Becton Dickinson is recalling BD Vacutainer LH blood collection tubes because they may cause false elevation of carboxyhemoglobin results when used with specific instruments.
Becton Dickinson is recalling BD Vacutainer Lithium Heparin blood collection tubes because they may cause false elevation of carboxyhemoglobin results when used with specific instruments.
Becton Dickinson is recalling BD Vacutainer LH blood collection tubes because they can cause false elevation of carboxyhemoglobin results when used with the IL GEM 4000 instrument.
Becton Dickinson is recalling specific blood collection tubes because they may cause falsely elevated carboxyhemoglobin results when used with the IL GEM 4000 instrument.
Becton Dickinson is recalling BD Vacutainer Lithium Heparin blood collection tubes because they may cause false elevation of carboxyhemoglobin results when used with specific instruments.
Becton Dickinson is recalling BD Vacutainer Lithium Heparin blood collection tubes because they may cause false elevation of carboxyhemoglobin results when used with specific instruments.
Becton Dickinson is recalling specific blood collection tubes because they may cause falsely elevated carboxyhemoglobin results when used with the IL GEM 4000 instrument.
Becton Dickinson is recalling BD Vacutainer PST Blood Collection Tubes because they may cause false elevation of carboxyhemoglobin results when used with the IL GEM 4000 instrument.
Becton Dickinson is recalling BD Vacutainer Lithium Heparin blood collection tubes because they may cause false elevation of carboxyhemoglobin results when used with specific instruments.
Becton Dickinson is recalling specific blood collection tubes because they may cause false elevation of carboxyhemoglobin results when used with the IL GEM 4000 instrument.