Health product recall

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

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

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

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number
  • 9031
  • 9051
Companies
Manufacturer
Merck Millipore Ltd.
Tullagreen
Carrigtwohill, Cork
T45 KD29
IRELAND