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Behring Nephelometer System - N Latex IGE (2014-06-16)
- Starting date:
- June 16, 2014
- Posting date:
- July 3, 2014
- 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-40227
Recalled Products
Behring Nephelometer System - N Latex IGE
Reason
Siemens healthcare diagnostics has confirmed an increase in the rate of technical flags with the N latex IGE mono reagent lots mentioned above. The errors can occur on calibration, qc and/or patient sample. No result is given with the technical flag. In such cases a calibration curve cannot be established. In rare cases, invalid QC results might be observed leading to invalid runs.
Affected products
Behring Nephelometer System - N Latex IGE
Lot or serial number
169658
169658A
169658B
169658C
Model or catalog number
OQTG15
Companies
- Manufacturer
-
Siemens Healthcare Diagnostics Products GmbH
Emil-Von-Behring-Str. 76
Marburg
35041
GERMANY