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Innovance D-Dimer
- Starting date:
- January 20, 2017
- Posting date:
- February 9, 2017
- 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-62138
Reason
An extrapolation in the Innovance D-Dimer OUS setting can lead to false negative (as well as to false positive) results on the Sysmex CS-Systems. The issue may only occur under the condition the following conditions:
- The result is falsely flagged with an antigen excess error that triggers an automatic re-measurement in a 1/19 dilution.
- The raw signal of the re-measurement is below the limit of blank (LOB) of the method. Under such conditions the low re-measurement raw value may be strongly affected by the signal noise of the optical system and can generate an erroneous low reading. The raw value will be corrected by the dilution factor and can be deduced from calibration curve in a false low range.
Affected products
Innovance D-Dimer
Lot or serial number
- 10445979
- 10445980
Model or catalog number
- OPBP03
- OPBP07
Companies
- Manufacturer
-
Siemens Healthcare Diagnostics Products Gmbh
Emil-Von-Behring-Str. 76
Marburg
35041
GERMANY