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

A. ImmunoCAP Allergen c6, Amoxicilloyl
B. ImmunoCAP Allergen c5, Ampicilloyl

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.

 

991D7
991D8
991D9
991DA
991DB
991DC

14-4451-01

Manufacturer

PHADIA AB
RAPSGATAN 7, P.O. BOX 6460
UPPSALA
75137
SWEDEN

 

 

990DS
990DT
990DU
990DV
990DW
990DX
990DY
990DZ

14-4450-01

Manufacturer

PHADIA AB
RAPSGATAN 7, P.O. BOX 6460
UPPSALA
75137
SWEDEN

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