Remel Selective Rapid Urea (2018-08-21)

Starting date:

August 21, 2018

Posting date:

September 7, 2018

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-67708

• 
  Reason
• 
  Affected products

Affected products

Remel Selective Rapid Urea

Reason

An internal technical investigation has confirmed that Remel Selective Rapid Urea (0.5ml) 24/PK R20389 Lot 341262 may fail performance testing specifications for H. pylori ATCC 43504. Per the Instructions for Use (IFU) the product should have a positive reaction with this microorganism and produce an intense pink-red appearance. Currently, the product may not show a positive reaction for intense pink-red color change appearance.

Affected products