Becton Dickinson recalls PST blood collection tubes (368035/368036) due to false high carboxyhemoglobin readings when used with IL GEM 4000 blood gas analyzers.
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.
Becton Dickinson is recalling PST blood collection tubes with catalog numbers 368035 and 368036. These tubes can cause false high carboxyhemoglobin (COHb) results when analyzed with the IL GEM 4000 blood gas instrument, which could lead to incorrect blood oxygen level assessments.
The PST tubes can produce false high carboxyhemoglobin readings when analyzed with the IL GEM 4000 blood gas analyzer. This could lead to incorrect blood oxygen level assessments, potentially affecting treatment decisions.
Healthcare professionals who use these tubes for blood collection and analyze samples with the IL GEM 4000 instrument are most at risk. Patients receiving blood tests using these tubes may also be affected.
Check for catalog numbers 368035 or 368036 on the tubes. The tubes have a unique device identifier (UDI) starting with (01)30382903680352 or (01)30382903680369.
Look for catalog numbers 368035 or 368036 on the tubes.
The recall is due to false elevation of carboxyhemoglobin (COHb) results when using these tubes with the IL GEM 4000 blood gas analyzer.
The official notice does not specify a remedy for this recall.
The recall does not indicate immediate safety risks to patients, but incorrect blood oxygen assessments could affect treatment.
We’ve drafted a message you can send Becton Dickinson to request your refund or repair — edit it as you like.
Subject: Recall Z-2306-2019 — Becton Dickinson Becton Dickinson Hello, I own a Becton Dickinson that is covered by recall Z-2306-2019 from Becton Dickinson. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.