IMMAGE Immunochemistry System Total Immunoglobulin E (IGE) Reagent and Cal (2019-09-04)

Starting date:

September 4, 2019

Posting date:

October 3, 2019

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-71129

Last updated: 2019-10-03

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  Reason
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  Affected products

Affected Products

IMMAGE Immunochemistry System Total Immunoglobulin E (IGE) Reagent and Cal

Reason

Patient samples with IGE concentrations in the assay extended analytical range (>500- 30,000 IU/ml) may generate false low results that recover within the initial undiluted (neat) range of 5-500 IU/ml. Diagnosis and treatment may be delayed if results are not evaluated in conjunction with patient symptoms or other clinical tests.

Affected products