iChemVELOCITY Urine Chemistry Strips (2017-12-04)

Starting date:

December 4, 2017

Posting date:

January 8, 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-65570

• 
  Reason
• 
  Affected products

Affected Products

iChemVELOCITY Urine Chemistry Strips

Reason

Iris Diagnostics has become aware of a strip manufacturing error where an incorrect pad was inadvertently placed in the location of the leukocytes pad. All other analytes are correct. This defect exists on a subset of vials belonging to Lot # 7212154 A, with the impacted vial numbers ranging from 01520 through 02401.

Affected products