CLINITEK Status+ (2016-01-25)

Starting date:

January 25, 2016

Posting date:

February 12, 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-57118

• Reason
• Affected products

Affected Products

A. CLINITEK Status+

Reason

An internal product review determined that there was an issue with software versions 2.60/2.4.0.0 and 2.61/2.4.1.0 for the CLINITEK Status+ Connect Systems, which could potentially affect patient results.

In the case that an operator transmits all of the data stored in the instrument to a LIS or data manager by selecting the "send all" function, the software will allow the operator to perform a urinalysis strip or cassette test while data is still being transferred. In this case, the instrument may be slow to respond. Depending on the amount of data being transferred and the speed at which it is transferred, there may be a delay in timing when the urinalysis reagents are read by the analyzer. This delay in real time may potentially affect patient results.

Affected products