Dimension Vista System - Multi 1 Sample Diluent (MULTI 1 SDIL) and Multi 2 Sample Diluent (MULTI 2 SDIL), CTNI Sample Diluent (CITNI SDIL) (2018-03-26)
- Starting date:
- March 26, 2018
- Posting date:
- May 1, 2018
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type III
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-66608
Affected products
A. DIMENSION VISTA SYSTEM - MULTI 2 SAMPLE DILUENT (MULTI 2 SDIL)
B. DIMENSION VISTA SYSTEM MULTI 1 SAMPLE DILUENT (MULTI 1 SDIL)
C. CTNI SAMPLE DILUENT (CTNI SDIL)
Reason
Siemens Healthcare Diagnostics has confirmed certain Dimension Vista diluent lots may have an incomplete slit on the septum in the cap of the vial. A diluent cap with a defective septum has the potential to cause erroneously elevated results if a sample is auto-diluted onboard the Dimension Vista System, due to a reduced volume of diluent being pipetted from the vial. Only a portion of each lot has defective septums and only a portion of visually defective septums are functionally defective.
Affected products
A. DIMENSION VISTA SYSTEM - MULTI 2 SAMPLE DILUENT (MULTI 2 SDIL)
Lot or serial number
7CDA79
7DDA70
Model or catalog number
10483586
KD694
Companies
- Manufacturer
-
Siemens Healthcare Diagnostics Inc.
500 GBC DRIVE, MAILSTOP 514, P.O. BOX 6101
Newark
19714
Delaware
UNITED STATES
B. DIMENSION VISTA SYSTEM MULTI 1 SAMPLE DILUENT (MULTI 1 SDIL)
Lot or serial number
7BDA81
Model or catalog number
10469971
KD693
Companies
- Manufacturer
-
Siemens Healthcare Diagnostics Inc.
500 GBC DRIVE, MAILSTOP 514, P.O. BOX 6101
Newark
19714
Delaware
UNITED STATES
C. CTNI SAMPLE DILUENT (CTNI SDIL)
Lot or serial number
7BDA34
Model or catalog number
10445205
KD692
Companies
- Manufacturer
-
Siemens Healthcare Diagnostics Inc.
500 GBC DRIVE, MAILSTOP 514, P.O. BOX 6101
Newark
19714
Delaware
UNITED STATES