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

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  Reason
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  Affected products

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