Remel BactiDisks Neisseria Gonorrhoeae (2019-12-02)

Starting date:

December 2, 2019

Posting date:

January 6, 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-71993

Last updated: 2020-01-07

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  Reason
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  Affected products

Affected Products

Remel BactiDisks Neisseria Gonorrhoeae

Reason

An internal technical review has led to an adjustment on the shelf life of the N. Gonorrhoeae strains listed in the table below to 182 days. Continued use of the below lots may exhibit reduced growth, which is evident to the user, as they are now beyond the 182 days post manufacture.

Affected products