NOVA LITE ANA

Starting date:

December 5, 2016

Posting date:

January 12, 2017

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-61718

• Reason
• Affected products

Reason

Inova Diagnostics, Inc. recently discovered that some of the glass slides have the incorrect product description on the masking of the slide. Approximately 3% of the glass slide lot received from the supplier contains the incorrect description of "e-ANCA" instead of "HEp-2" on the masking. The barcode on the glass slide correctly reflects the " HEp-2" product information, and the performance of the slides is not in any way affected by this error.

Affected products