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
Affected Products
- MicroScan Neg/Urine Combo Panel
- 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
-
MicroScan Neg/Urine Combo Panel
Lot or serial number
Not applicable.
Model or catalog number
B1017-426
Companies
- Manufacturer
-
Beckman Coulter Inc.
250 S. Kraemer Blvd.
Brea
92821
California
UNITED STATES
B. LabPro Data Management System
Lot or serial number
Software Version 4.42
Model or catalog number
C22259
C22261
Companies
- Manufacturer
-
Beckman Coulter Inc.
250 S. Kraemer Blvd.
Brea
92821
California
UNITED STATES