VITROS Chemistry Products VersaTips (2021-01-22)

Starting date:

January 22, 2021

Posting date:

February 5, 2021

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-74923

Last updated:
2021-02-05

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  Reason
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  Affected products

Affected Products 

VITROS Chemistry Products VersaTips

Reason

Ortho Clinical Diagnostics received customer complaints for the following condition codes on a Vitros 5600 system:

TMN-410: UIA Metering Aspirate Servo - pump travel limit reached

TEN-410: Uslide Metering Aspirate Servo - pump travel limit reached

TML-49A: UIA Metering Cuvetip seal failure at 1 tip sealer

Initial investigation found that the increase in these condition codes was related to improper tip sealing when using one specific lot of VITROS VersaTips. Upon inspection, a deformity was noted in some tips from this lot. The issue is intermittent as not all tips from this lot are affected. No other lots appear to be affected. This deformity can lead to an improper seal of the tip on the proboscis. An improperly sealed tip may cause a condition code to post but will not always post a condition codes or suppress result reporting.

Affected products