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Health product recall

REMEL PATHODX STREP GROUP B LATEX (2016-06-15)

Starting date:
June 15, 2016
Posting date:
July 7, 2016
Type of communication:
Medical Device Recall
Subcategory:
Medical Device
Hazard classification:
Type III
Source of recall:
Health Canada
Issue:
Medical Devices
Audience:
Healthcare Professionals, General Public, Hospitals
Identification number:
RA-59264

Affected products

A. REMEL PATHODX STREP GROUP B LATEX

Reason

An internal investigation has identified that this lot may have an incorrect label attached to the kit (outer) carton that incorrectly identifies the product as PathoDx strep grouping UNIVERSAL kit (R62025) lot #:1782772.

Affected products

A. REMEL PATHODX STREP GROUP B LATEX

Lot or serial number

1782772

Model or catalog number

R62025

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