LetsGetChecked Blood & Urine Sample Collection Kit Device (2019-07-11)

Starting date:

July 11, 2019

Posting date:

August 9, 2019

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-70669

Last updated: 2019-08-09

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  Reason
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  Affected products

Affected Products

A. LetsGetChecked Blood Sample Collection Kit Device

B. LetsGetChecked Blood & Urine Sample Collection Kit

Reason

The kit contains BD microtainer tubes subject to recall. The tubes are being recalled as there is the potential for blood leakage due to a hole or damage at the made of the tube.This defect could result in blood exposure from the leaked sample or potential erroneous results due to an inappropriate blood-to-additive ratio. There is also potential for tube underfill due to another type of tube damage where the blood does not leak, and therefore may not be detected by the user. This could lead to potential underfill with an incorrect blood-to-additive ratio and potential erroneous results if the sample is tested.

Affected products