K-ACT Kaolin ACT Tubes (2020-11-09)

Starting date:

November 9, 2020

Posting date:

November 27, 2020

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-74411

Last updated:
2020-11-27

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  Reason
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  Affected products

Affected Products

K-ACT Kaolin ACT Tubes

Reason

The reason for the recall is device malfunction due to a quality issue in the manufacturing process. It was observed that some tubes had caps that were split along the side of the flip top. When this defect occurs, the cap does not stay on when the flip top is opened. The defect is visible to the user. If a defective tube is used, the sample could potentially leak, creating potential for biohazardous exposure.

Affected products