Vitros Systems (2014-04-11)

Starting date:

April 11, 2014

Posting date:

May 5, 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-39319

• Reason
• Affected products

Recalled Products

A. Vitros Chemistry Products 5.1 FS Chemistry System - Analyzer
B. Vitros Chemistry Products 5.1 FS Chemistry System - Refurbished
C. Vitros Chemistry Products 5.1 FS Chemistry System - Instrument
D. Vitros 5600 Integrated System - Instrument
E. Vitros 5600 Integrated System
F.  Vitros 4600 Chemistry System - Hardware

Reason

OCD has issued a recall due to the potential for biased results when a multiple window (MW) code is associated with results generated by the Vitros 5600 Integrated system, Vitros 4600 Chemistry system and Vitros 5.1 Chemistry system. MW codes may be associated with results from any of the following Vitros Chemistry products using multiple point (Multipoint) rate measurements: Alt slides, ALKP slides, AST slides, CHE slides, CK slides, GGT slides, LDH slides. Multipoint rate assays measure enzyme activity via multiple readings which are used to generate a kinetic curve and calculate results. The MW algorithm assesses the validity of the kinetic curve. An MW code is generated if a single point exceeds predetermined limits, provided that all surrounding values are within acceptable limits.

Affected products