MicroScan Neg/Urine Combo Panel and LabPro Data Management System (2019-05-07)

Starting date:

May 7, 2019

Posting date:

January 10, 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-72063

Last updated: 2020-01-10

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  Reason
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  Affected products

Affected Products

1. MicroScan Neg/Urine Combo Panel
2. LabPro Data Management System

Reason

As a result of an internal investigation, Beckman Coulter has determined that for ESBL confirmed organisms (e.coli, mirabilis, k.pneumoniae, k.oxytoca and k.pneumoniae/oxytoca) LabPro 4.42 Pu-7 is reporting cefazolin (CFZ) on MicroScan Neg Urine Combo 74 (NUC74) using standard interpretations of s, n/r and r, instead of changing the interpretation to r* (predicted resistance).

Affected products