DIMENSION CLINICAL CHEMISTRY, DIMENSION XPAND, DIMENSION EXL SYSTEMS (2019-07-19)
- Starting date:
- July 19, 2019
- Posting date:
- August 2, 2019
- 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-70597
Last updated: 2019-08-02
Affected Products
A. DIMENSION CLINICAL CHEMISTRY SYS. - FERRITIN (FERR) FLEX REAGENT CARTRIDGE
B. DIMENSION XPAND SYSTEM - FERRITIN (FERR) ASSAY
C. DIMENSION EXL SYSTEM - FERRITIN (FERR) ASSAY
Reason
Siemens Healthcare Diagnostics has confirmed that the Dimension® Ferritin (FERR) Flex® reagent lot listed in Table 1 may exhibit a negative bias during the open well stability time period. Siemens has determined that FERR values can potentially decrease by -50% at a concentration of 22 ng/mL [μg/L] and -48% at a concentration of 285 ng/mL [μg/L] after a 10 day open well period. Siemens has also determined that FERR values can potentially decrease by approximately -15% after a 3 day open well period. Quality control and patient samples are affected similarly.
Affected products
A. DIMENSION CLINICAL CHEMISTRY SYS. - FERRITIN (FERR) FLEX REAGENT CARTRIDGE
Lot or serial number
EA9227
Model or catalog number
RF440
Companies
- Manufacturer
-
Siemens Healthcare Diagnostics Inc.
500 GBC Drive, Mailstop 514, P.O. Box 6101
Newark
19714
Delaware
UNITED STATES
B. DIMENSION XPAND SYSTEM - FERRITIN (FERR) ASSAY
Lot or serial number
EA9227
Model or catalog number
10444946
RF440
Companies
- Manufacturer
-
Siemens Healthcare Diagnostics Inc.
500 GBC Drive, Mailstop 514, P.O. Box 6101
Newark
19714
Delaware
UNITED STATES
C. DIMENSION EXL SYSTEM - FERRITIN (FERR) ASSAY
Lot or serial number
EA9227
Model or catalog number
10444946
RF440
Companies
- Manufacturer
-
Siemens Healthcare Diagnostics Inc.
500 GBC Drive, Mailstop 514, P.O. Box 6101
Newark
19714
Delaware
UNITED STATES