Trace Elements Normal Range Serum Control (2019-11-22)

Starting date:

November 22, 2019

Posting date:

December 13, 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-71869

Last updated: 2019-12-13

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  Reason
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  Affected products

Affected Products

Trace Elements Normal Range Serum Control

Reason

Incorrect value on the product IFU for the analyte of Manganese. The value was mistyped as a value of 2.69 and range of 2.29 - 3.09 on the IFU, when it was reported as 0.48 and 0.41 - 0.55 respectively.

Affected products