Dimension Vista LOCI Reaction Vessels (2018-07-17)

Starting date:

July 17, 2018

Posting date:

August 17, 2018

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type III

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-67378

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  Reason
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  Affected products

Affected products

Dimension Vista LOCI Reaction Vessels

Reason

Siemens Healthcare Diagnostics has received customer complaints regarding Dimension Vista LOCI Reaction Vessels causing vessel pickup errors. Supplier internal investigation has identified the potential for a LOCI reaction vessel to contain a small hole or indent on the top of the vessel. This may result in the vista system generating a ""vessel pickup error"" when the defective vessel is not successfully picked up by the vacuum system. The error is resolved when the defective vessel is removed from the system.

Not all vessels are impacted. The frequency of defective vessels is low. Any loci reaction vessel lot manufactured prior to lot NH3912618 may be impacted. Siemens continues to manage inventory as Siemens works with the supplier to resolve this quality issue.

Affected products