Optilite Beta-2-microglobulin Urine Kit (2018-03-09)

Starting date:

March 9, 2018

Posting date:

April 3, 2018

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type II

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-66328

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  Reason
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  Affected products

Affected products

OPTILITE BETA-2 MICROGLOBULIN URINE KIT

Reason

Following an external complaint, investigations were reviewed on the 26/02/2018 and concluded the antigen excess protection of the assay at the initial dilution is only up to 18.4 mg/L (doc. 1 IFU). This does not meet the antigen excess protection (760 mg/L) stated in the IFU.

Affected products