Minicon Clinical Sample Concentrators (B-15 & CS-15) (2018-06-11)

Starting date:

June 11, 2018

Posting date:

June 29, 2018

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-67130

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  Reason
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  Affected products

Affected products

Minicon Clinical Sample Concentrators (B-15 & CS-15)

Reason

Since the 22nd of February 2017, 39 Minicon IVD complaints have been received.  97% of the complaints received were for device failing to concentrate the samples within the internal specification of less than or equal to 3 hours. A trend report to the Irish Competent Authority (HPRA) was submitted on March 7th 2018, (HPRA ref v35094).  On May 3rd 2018, the HPRA requested that a field safety notice be issued based on their opinion that there exists a potential risk to patient safety.

Affected products