ARCHITECT iGentamicin Reagent Kit (2020-04-28)

Starting date:

April 28, 2020

Posting date:

May 8, 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-73039

Last updated: 2020-05-08

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  Reason
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  Affected products

Affecetd Products

1. ARCHITECT iGentamicin Reagent Kit

Reason

This recall is to inform customers of a product correction for the architect iGentamicin assay, and to provide instructions on the actions the laboratories must take.

Abbott identified that samples tested for architect stat high sensitive troponin-I and stat high sensitivity troponin-I assays (LN 3P25 and LN 2R98) may show interaction when processed directly after the architect iGentamicin (LN 1P31) assay and patient results might be impacted. Preliminary results from Abbott internal analysis of field data from these two assays show false elevation of patient results with a frequency of 0.002%. 

At this time, there are no indications that the issue impacts other assays, however, the investigation is ongoing. Further, corrective actions may be implemented and communicated upon completion of the investigation.

 

Affected products