Health product recall

Anti Human Anti Hemophilus Influenza EIA Kit (2019-07-26)

Starting date:
July 26, 2019
Posting date:
August 23, 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-70799



Last updated: 2019-08-23

Affected Products

Anti Human Anti Hemophilus Influenza EIA Kit

Reason

Investigations into customer complaints have shown an average positive bias of 27.3% With a probability of low QC failure of 42% using manual testing methods. A positive bias of 43.7% With a probability of failure of 45% (low QC) and 43% (high QC) was observed when using automated testing methods. It was identified that the positive bias is more pronounced at lower concentrations, and presents inconsistently across individual plates.

Affected products

Anti Human Anti Hemophilus Influenza EIA Kit

Lot or serial number

413170

435314

Model or catalog number

MK016

Companies
Manufacturer

The Binding Site Group Limited

8 Calthorpe Road

Birmingham

B15 1QT

UNITED KINGDOM