Health product recall

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

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

K-ACT Kaolin ACT Tubes

Lot or serial number

1-19, 2-19

Model or catalog number

K-ACT

Companies
Manufacturer
Helena Laboratories, Inc.
1530 Lindbergh Drive, P.O. Box 752
Beaumont
77704-0752
Texas
UNITED STATES