Urinalysis Control Level 2 (2019-07-25)

Starting date:

July 25, 2019

Posting date:

August 9, 2019

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-70659

Last updated: 2019-08-09

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  Reason
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  Affected products

Affected Products

Urinalysis Control Level 2

Reason

Randox is re-assigning the analyte range for leukocytes for use with the Siemens Multistix method to negative to 3+. Updated value sheets are now available on www.randox.com under support and documentation. No other lots or products are affected by this issue.

Affected products