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MYLA SERVER HP PROLIANT DL380-G8 IVD MYLA SERVER (2015-11-04)
- Starting date:
- November 4, 2015
- 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-55976
Affected Products
MYLA SERVER HP PROLIANT DL380-G8 IVD MYLA SERVER
Reason
Under certain conditions, Myla Software, when connected to a Vitek 2 System and to a laboratory information system (LIS) allowing the re-use of specimen ID, presents the potential to link a result from Vitek 2 to the wrong patient and then upload those results to the LIS.
Affected products
MYLA SERVER HP PROLIANT DL380-G8 IVD MYLA SERVER
Lot or serial number
Myla Clinical 3.X to 4.1 DL380
Myla Clinical 3.X to 4.1 ML350
Myla Master DVD 3.2 CLI DL380
Myla Master DVD 4.0 Clinique
Myla Master DVD 4.1 Clinique
Model or catalog number
415358 MASTER 3.2 CLI DL380
416546 MASTER 4.0 CLINIC
417191 MASTER 4.1 CLINIC
419071 CLINICAL V3.X TO V4.1 DL380 SERVER
419072 CLINICAL V3.X TO V 4.1 ML350 SERVER
Companies
- Manufacturer
-
Biomerieux Inc.
595 Anglum Road
Hazelwood
63042
Missouri
UNITED STATES