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Health product recall

N/T Protein Standards SL

Starting date:
October 28, 2016
Posting date:
November 15, 2016
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-61050

Affected Products

Reason

Siemens Healthcare Diagnostics has confirmed that control values may be found out of range (>+/-15%) for N Antiserum to prealbumin using N/T protein control SL/H. Furthermore, controls may be flagged with a turbidity flag (x-flag). We have no indication that other analytes in N/T protein control SL/H are affected by this issue.

Affected products

N/T Protein Standards SL

Lot or serial number
  • 084847
  • 084847C
  • 084847D
  • 084847E
  • 084847F
Model or catalog number
  • OQIP13
Companies
Manufacturer
Siemens Healthcare Diagnostics Products Gmbh
Emil-Von-Behring-Str. 76
Marburg
35041
GERMANY