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CLINITEK NOVUS ANALYZER (WITH RACK) (2015-07-02)
- Starting date:
- July 2, 2015
- Posting date:
- July 17, 2015
- 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-54266
Affected Products
A. CLINITEK NOVUS ANALYZER (WITH RACK)
Reason
Siemens has identified a potential reporting error with the CLINITEK Novus Analyzer. If the report clarity setting is disabled, there is a potential for the specific gravity, Leukocytes, Albumin, p:c ratio, and/or the a:c ratio to be misreported. This issue impacts systems on SW Versions 1.1 and 1.2.
Affected products
A. CLINITEK NOVUS ANALYZER (WITH RACK)
Lot or serial number
- S001046
- S001259
- S001294
- S001295
- S001308
- S001331
- S001333
- S001524
- S001555
- S001311
- S001312
- S001313
- S001328
- S001520
- S001550
- S001553
- S001569
Model or catalog number
10494134
10844545
10697937
Companies
- Manufacturer
-
Siemens Healthcare Diagnostics Manufacturing Ltd.,
Northern Road,
Sudbury, Suffolk, United Kingdom
CO10 2XQ