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Health product recall

User-Fillable Reagent Bottle (2015-05-06)

Starting date:
May 6, 2015
Posting date:
January 25, 2016
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-56772

Affected Devices

User-Fillable Reagent Bottle

Reason

Serial numbers were repeated on different bottles on this lot of User-Fillable Reagent Bottles. If Autostainer Link instrument reads a serial number that has been assigned previously, a bottling error will occur.

Affected products

User-Fillable Reagent Bottle

Lot or serial number

10092763

Model or catalog number

SK200

Companies
Manufacturer
Dako North America, Inc.
6392 via Real
Carpinteria
93013
California
UNITED STATES