Lyphochek Specialty Immunoassay Control (2019-04-04)

Starting date:

April 4, 2019

Posting date:

May 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-69818

Last updated: 2019-05-03

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  Reason
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  Affected products

Affected Products

Lyphochek Specialty Immunoassay Control

Reason

Intact PTH may not meet the reconstituted and refrigerated stability claim as printed in the package inserts. All other claims for these lots of Lyphochek Specialty Immunoassay Control remain unchanged.

Affected products