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ENGEN LABORATORY AUTOMATION SYSTEM (2015-04-07)
- Starting date:
- April 7, 2015
- Posting date:
- May 6, 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-53243
Recalled Products
A. ENGEN LABORATORY AUTOMATION SYSTEM
Reason
Ortho Clinical Diagnostics (OCD) internal testing has confirmed instances where VITROS 5,1 FS, 4600 or 5600 systems allowed testing of multiple assays using a single urine specimen, regardless of the pretreatment requirements for each selected assay, potentially leading to biased patient results. Urine samples for use with VITROS CA, MG and PHOS slides require acidification (pretreatment). The ENGEN system software currently does not route these samples to the manual high priority exit location for pretreatment as intended. In addition, the Engen system software currently allows the ordering of invalid assay combinations that include urine samples with differing requirements with regard to pretreatment. Depending upon the assay, urine samples need to be acidified, alkalized, extracted or not treated prior to being processed on VITROS systems.
Affected products
A. ENGEN LABORATORY AUTOMATION SYSTEM
Lot or serial number
J16XQH4J
J1HX7S4J
J41BCY4J
J953234
J953244
JCT20Q3J
Model or catalog number
ENGEN
Companies
- Manufacturer
-
Thermo Fisher Scientific Oy
P.O. Box 100, Ratastie 2
Vantaa
01621
FINLAND