Health product recall

QUANTA Lite Actin IgG ELISA (2019-12-20)

Starting date:
December 20, 2019
Posting date:
January 10, 2020
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-72093

Last updated: 2020-01-10

Affected Products

QUANTA Lite Actin IgG ELISA

Reason

Recall due to an increased positivity rate. The specificity claims in the direction insert are not being met.

Affected products

QUANTA Lite Actin IgG ELISA

Lot or serial number

49578

Model or catalog number

708785

Companies
Manufacturer

Inova Diagnostics Inc.

9900 Old Grove Road

San Diego

92131

California

UNITED STATES