Dimension Vista System - Gentamicin Assay, Dimension Clinical Chemistry System - Gentamicin, Dimension Xpand System - Genamicin (Gent) Assay, Dimension EXL System Gentamicin (Gent) Assay (2018-04-24)
- Starting date:
- April 24, 2018
- Posting date:
- May 25, 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-66854
Affected products
- Dimension Vista System - Gentamicin Assay
- Dimension Clinical Chemistry System - Gentamicin
- Dimension Xpand System - Gentamicin (Gent) Assay
- Dimension EXL System - Gentamicin (Gent) Assay
Reason
Siemens Healthcare Diagnostics has confirmed Dimension Gentamicin (Gent) lot bb8159 may exhibit inaccuracy for Quality Control (QC) and patient samples at the low end of the analytical measurement range. Maximum negative bias of 100% and 48% were observed for patient samples at 0.9 ug/ml [1.94 umol/l] and 1.9 ug/ml [4.1 umol/l], respectively. Patient samples at 2.6 ug/ml [5.62 umol/l] did not show a bias. The bias is due to the calibration curve not showing separation between the level 1 and level 2 calibrators. Based on the investigation, lots 17135bc, 17150bf, 17159bd, 17178ac, 17269bd, and 17312bb may also exhibit a similar separation between level 1 and level 2 calibrators over time.
Affected products
A. Dimension Vista System - Gentamicin Assay
Lot or serial number
12269BD
17135BC
17150BF
17159BD
17178AC
17312BB
Model or catalog number
K4012
Companies
- Manufacturer
-
Siemens Healthcare Diagnostics Inc.
500 GBC DRIVE, MAILSTOP 514, P.O. BOX 6101
Newark
19714
Delaware
UNITED STATES
B. Dimension Clinical Chemistry System - Gentamicin
Lot or serial number
BB8159
EB8115
FB8275
Model or catalog number
DF12
Companies
- Manufacturer
-
Siemens Healthcare Diagnostics Inc.
500 GBC DRIVE, MAILSTOP 514, P.O. BOX 6101
Newark
19714
Delaware
UNITED STATES
C. Dimension Xpand System - Gentamicin (Gent) Assay
Lot or serial number
BB8159
EB8115
FB8275
Model or catalog number
DF12
Companies
- Manufacturer
-
Siemens Healthcare Diagnostics Inc.
500 GBC DRIVE, MAILSTOP 514, P.O. BOX 6101
Newark
19714
Delaware
UNITED STATES
D. Dimension EXL System - Gentamicin (Gent) Assay
Lot or serial number
BB8159
EB8115
FB8275
Model or catalog number
DF12
Companies
- Manufacturer
-
Siemens Healthcare Diagnostics Inc.
500 GBC DRIVE, MAILSTOP 514, P.O. BOX 6101
Newark
19714
Delaware
UNITED STATES