VITROS Chemistry Kits (2015-09-29)

Starting date:

September 29, 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-55638

• Reason
• Affected products

Affected Products

A. VITROS Chemistry Products Calibrator Kit 9
B. VITROS Chemistry Products Calibrator Kit 9

Reason

Ortho Clinical Diagnostics, Inc. (OCD) initiated this recall due to the potential for an increase in U90-382 or 6LU condition codes (wash errors) when using Vitros Calibrator Kit 9, Lot 0954. When a U90-382 or 6LU condition code occurs, the Vitros System suppresses the result and no result is reported. The increase in condition codes primarily occurs when using Vitros DGXN and PHYT slides. All numerical results obtained are valid providing that no wash errors occurred and quality control results were within acceptable limits.

Affected products