ImmunoCAP Allergen c6, Amoxicilloyl and c5, Ampicilloyl (2017-12-28)

Starting date:

December 28, 2017

Posting date:

January 12, 2018

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-65684

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  Reason
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  Affected products

Affected products

1. ImmunoCAP Allergen c6, Amoxicilloyl
2. ImmunoCAP Allergen c5, Ampicilloyl

Reason

Somagen Diagnostics along with Thermofisher Scientific would like to notify you of an urgent recall and backorder of ImmunoCAP Allergen c5, Ampicilloyl product code 14-4450-01 and ImmunoCAP Allergen c6, Amoxicilloyl product code 14-4451-01.  An internal monitoring stability study has indicated that stability specifications have not been met and were in fact half the intended expiry date of 12 months. There is a possibility that samples with a low positive concentration may be incorrectly reported as negative.  Any reported test results below the assay Limit of Qualification (LOQ) should be disregarded as these results may be invalid.  No complaints or injuries to patients have been reported.

Affected products