Simplexa COVID-19 Positive Control Pack (2021-09-23)

Starting date:

September 23, 2021

Posting date:

October 15, 2021

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type II

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-76649

Last updated: 2021-10-15

• Reason
• Affected products

Affected Products 

Simplexa COVID-19 Positive Control Pack

Reason

A subset of Simplexa? Covid-19 positive control pack lots are at risk of amplification inhibition due to one of the raw materials used in the positive control reaction mix. This could lead to a potential invalid result.

Affected products