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Health product recall

RapidQC Complete Level 2 (2014-07-03)

Starting date:
July 3, 2014
Posting date:
July 15, 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-40475

Recalled Products

  1. RapidQC Complete Level 2 

Reason

Siemens Healthcare Diagnositcs has confirmed an error in the expected values chart pertaining to the level 2 pH control range for all Siemens blood gas instruments, namely the RAPIDPoint 400/405/500 systems, RAPIDLab 1200 series systems, RAPIDLab 248/348/348ex systems,RAPIDLab 800 series systems and the RAPIDPoint 340/350 systems.

Due to this error, the recovery of pH for RapidQC complete, level 2, lot # 362303, is elevated on all siemens blood gas systems. It is also possible that some instruments may, on occasion, recover pH out of range high. However, the published target ranges for all other analytes are unaffected.

Affected products

A. RapidQC Complete Level 2 

Lot or serial number
  • 362303
Model or catalog number
  • 10309926
Companies
Manufacturer
Siemens Healthcare Diagnostics Inc.
511 Benedict Ave.
Tarrytown
10591
New York
UNITED STATES