Health product recall

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

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

Remel Selective Rapid Urea

Lot or serial number

341262

Model or catalog number

R20389

Companies
Manufacturer
Remel Inc.
12076 Santa Fe Drive
Lenexa
66215
Kansas
UNITED STATES