QUANTA Lite Histone 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-72091

Last updated: 2020-01-10

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  Reason
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  Affected products

Affected Products

QUANTA Lite Histone ELISA

Reason

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

Affected products