QuikLYTE Dilution Check (2015-02-25)

Starting date:

February 25, 2015

Posting date:

March 27, 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-52699

• Reason
• Affected products

Recalled Products

A. QuikLYTE Dilution Check

Reason

Siemens Healthcare Diagnostics has confirmed complaints of failing dilution checks when using QuikLYTE dilution check Lot 4MD707. This lot may exhibit a positive bias possibly beyond 5% that can result in a dilution check failure or may result in an unnecessary correction if the bias is between 1 - 5%.  A dilution check failure prevents complete installation of the QuikLYTE integrated multisensor as described in the dimension operator's guide.

Affected products