VITROS® Automation Solutions configured with Thermo Scientific Aliquoter & Labeller Module (2020-11-23)
- Starting date:
- November 23, 2020
- Posting date:
- December 11, 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-74519
Last updated: 2020-12-10
Affected Products
A. ENGEN AUTOMATED SAMPLE HANDLING SYSTEM
B. THERMO SCIENTIFIC - VITROS AUTOMATION SOLUTIONS WITH TCAUTOMATION SYSTEM
Reason
A software anomaly that has the potential to allow two secondary tubes from different primary samples to be labelled with the same sample IDs. Thermo Fisher Scientific has been unable to replicate the issue, as it requires a very specific set of events that must occur in a very specific time sequence. However, a contributing cause for this was that the Aliquoter Module was improperly initialized, as sample tubes were still in the module.
Affected products
A. ENGEN AUTOMATED SAMPLE HANDLING SYSTEM
Lot or serial number
J16XQH4J
Model or catalog number
ENGEN
Companies
- Manufacturer
-
Thermo Fisher Scientific Oy
P.O. Box 100, Ratastie 2
Vantaa
01621
FINLAND
B. THERMO SCIENTIFIC - VITROS AUTOMATION SOLUTIONS WITH TCAUTOMATION SYSTEM
Lot or serial number
J953116
J953244
Model or catalog number
6844300
6844301
Companies
- Manufacturer
-
Thermo Fisher Scientific Oy
P.O. Box 100, Ratastie 2
Vantaa
01621
FINLAND