Dimension Vista System ? High Sensitivity Troponin I (TNIH) (2020-07-27)

Starting date:

July 27, 2020

Posting date:

August 28, 2020

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type II

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-73767

Last updated:
2020-08-28

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  Reason
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  Affected products

Affected Products

Dimension Vista System ? High Sensitivity Troponin I (TNIH)

Reason

Siemens has observed a negative bias across the analytical measurement range of the TnIH assay. The average bias observed for patient samples using the dimension vista TnIH lots 20008bb, 20035BC, and 20135BB when compared with a control TnIH lot was -20% for lot 20008bb and -23% for lot 20135BB. A maximum bias of -26% in patient samples around the 99th percentile with these specific lots was observed. Quality control will not detect the negative patient bias. TnIH lot 20008bb and lot 20035BC contain the same reagents therefore, performance of the two lots is equivalent.

Affected products