Cobas 4800 System Sample Preparation Kit 2 (2019-12-02)

Starting date:

December 2, 2019

Posting date:

January 6, 2020

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type III

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-72005

Last updated: 2020-01-07

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  Reason
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  Affected products

Affected Products

Cobas 4800 System Sample Preparation Kit 2

Reason

Following the information provided by our manufacturer on internal investigation of customer complaints on the cobas 4800 System Sample Preparation Kit 2 (cat # 06979521190, lots f08212, f17135), we would like to inform you of a situation where sample over-quantification (used for HIV-1 test) and invalid controls (used for HCV test) was documented. Another product lot was identified but never distributed in Canada (cat # 06979513190 lot f17079). The manufacturer advised us on 02-Dec-2019.

Affected products