Cobas PCR Media Dual Swab Sample Kit (2018-02-14)

Starting date:

February 14, 2018

Posting date:

May 11, 2018

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-66734

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  Reason
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  Affected products

Affected products

Cobas PCR Media Dual Swab Sample Kit

Reason

This urgent medical device correction is to inform you about the possibility that some Cobas PCR Media Dual Swab Sample Kit, lot y09528 might be missing the lot labels on the outside of the kit box. This label is normally affixed on the outer kit carton and contains the Kit Batch Number, Expiration Date, and Global Trade Item Number (GTIN). However, the packets inside the kit box are appropriately labeled with the corresponding kit lot information and expiration date. There is no impact to the performance characteristics of the product or tests that utilized this swab.

Affected products