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[Recalled] BD Vacutainer LH (Lithium Heparin) 68 I.U. Plus Blood Collection Tubes, Catalog Number 368884 — False elevation of carboxyhemoglobin (COHb) results have been reported when usi… | FDA 2019-06-12

recall fda device united-states

Authorities recorded a safety problem with this product. The details below come directly from the government recall notice.

Recall details

ProductBD Vacutainer LH (Lithium Heparin) 68 I.U. Plus Blood Collection Tubes, Catalog Number 368884
Brand / manufacturerBecton Dickinson & Company
Categorydevice
Issuing authorityFDA_DEVICE
ReferenceZ-2309-2019
Country of noticeUnited States
Risk levelClass II
Hazard typerecall
Notice date12 June 2019
EAN / barcode30382903659037

Why it was recalled

According to the FDA_DEVICE notice, the identified hazard is: 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.

This Class II recall concerns device products distributed in United States and was recorded by FDA_DEVICE. Recalls in this category are published so that owners, retailers, and importers can identify affected units and act quickly.

What to do if you own this product

Check whether your unit is affected and follow the authority's guidance before further use.

Read the full official notice →

Related recalls from Becton Dickinson & Company

This page indexes a public government recall notice for reference. We do not sell or verify this product; always confirm the current status on the authority's official site.

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