Assay Tip/Assay Cup (2019-08-15)

Starting date:

August 15, 2019

Posting date:

August 30, 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-70845

Last updated: 2019-09-05

• Reason
• Affected products

Affected Products

Assay Tip/Assay Cup

Reason

Assaytips were identified with abnormal internal structure in some lots. The assaytips are part of the assaytip / assaycup tray (product no. 05694302001). Recently, Roche has received a small number of customer complaints regarding defective assaytips. The affected assaytip / assaycup tray lots have been distributed from August 2018 until July 2019 (list of affected lots above). Internal investigation shows that the average amount of potentially affected assaytips in those lots is approximately 1.5%. The overall incidence rate represents 0.14% Of the assaytips production since the introduction of the cobas e 801.

Affected products