iChem VELOCITY Urine Chemistry strips (2018-10-10)

Starting date:

October 10, 2018

Posting date:

November 2, 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-68176

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  Reason
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  Affected products

Affected products

iChem VELOCITY Urine Chemistry strips

Reason

Beckman Coulter has become aware of an increase in the sensitivity of the urobilinogen reaction via customer reports of falsely elevated (false positive) urobilinogen patient results for iChemVELOCITY urine chemistry strips. Affected strips are: lot numbers beginning with lot 7212143 Except for: 7212146, 7212148, 7212160, 7212162, 7212163 and 7212164.

Patient results at the high end of the normal range for urobilinogen may be reported as abnormal (the first positive range) indicating an erroneous above normal result. This affects the 2 mg/dl reportable range (first abnormal range). As the worst case scenario, erroneous results released out of the lab may lead to additional minimally invasive work-up, including venipuncture resulting in temporary injury to the patient. This issue is not detected by quality control. There is no impact to the results of other analytes on the strip.

Affected products