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N Latex B2 Microglobulin (2014-10-01)

Starting date:
October 1, 2014
Posting date:
October 10, 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-41747

Recalled Products

N Latex B2 Microglobulin

Reason

Siemens Healthcare Diagnostics has received a small number of complaints about calibration failure with N Latex B2 Microglobulin. In rare cases the signal generated at the highest calibration point can exceed the analog-digital converter capacity of an affected BN system. This effect does not allow the establishment of a calibration curve due an invalid calibration point measurement.

Affected products

N Latex B2 Microglobulin

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number

OQWU15

Companies
Manufacturer
Siemens Healthcare Diagnostics Products GmbH
Emil-Von-Behring-Str. 76
Marburg
35041
GERMANY