ADVIA Centaur CP System Instruments (2016-04-04)

Starting date:

April 4, 2016

Posting date:

April 22, 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-58038

• Reason
• Affected products

Affected products

A. ADVIA CENTAUR CP SYSTEM-INSTRUMENT CLASS II

B. ADVIA CENTAUR CP SYSTEM-INSTRUMENT CLASS III

C. ADVIA CENTAUR CP SYSTEM-INSTRUMENT CLASS IV

Reason

There are two inaccuracies that exist in the ADVIA Centaur CP operator's guide, appendix D, pre-set tube types. The first refers to the sample volume supported by the system when using the EZEE-NEST cup to process samples. The operator's guide states that sample volumes greater than 50 ul can be used, however volumes greater than 150 ul cannot be used when using an EZEE-NEST insert cup. The second refers to the use of the universal cup adaptor with an EZEE-NEST insert cup in 65-mm sample racks. Siemens has determined that the height of an EZEE-NEST insert cup with universal cup adaptor fitted on a 65-mm sample rack will not fit into the sample compartment. No samples will be processed.

Affected products