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Health product recall

APTIMA Urine Specimen Collection Kit (2014-04-17)

Starting date:
April 17, 2014
Posting date:
January 9, 2015
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-43201

Recalled Products

APTIMA Urine Specimen Collection Kit

Reason

Labelling Error - The inner pouches were incorrectly labelled as "" APTIMA unisex swab collection kit for endocervical and male urethral swab specimens"". The outer box of the kit is identified correctly as APTIMA urine collection kits.

Affected products

APTIMA Urine Specimen Collection Kit

Lot or serial number

27232
27233
27234

Model or catalog number

301040-01

Companies
Manufacturer
Gen-Probe Incorporated, a wholly owned subsidiary of Hologic, Inc.,
10210 Genetic Center Drive,
San Diego.
92121
California
UNITED STATES