VITROS 4600 and 5,1 FS Chemistry Systems (2015-11-12)

Starting date:

November 12, 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-56286

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  Reason
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  Affected products

Affected Products

1. VITROS 5,1 FS Chemistry System
2. VITROS 5,1 FS Chemistry System
3. VITROS 4600 Chemistry System

Reason

Ortho Clinical Diagnostics (OCD) has issued this recall due to a software anomaly that may potentially occur on Vitros 4600 or 5,1 FS Systems. OCD recently identified that under very specific conditions, the temperature in the Microwell Subsystem (included on Vitros 3600 and 5600 Systems) may potentially be out of range without the system properly alerting the operator. Although Vitros 4600 and 5,1 FS systems do not include a Microwell Subsystem, it utilizes the same software as Vitros 3600 and 5600 Systems. OCD has estimated that there is a less than 1 in 14 million possibility that this anomaly could occur in the Microslide or Microtip subsystems included on Vitros 4600 or 5,1 FS Systems.

Affected products