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Health product recall

Histostain-SP Kit

Starting date:
February 24, 2017
Posting date:
March 24, 2017
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-62750

Reason

Histostain-SP kits lot numbers 1704222A and 1760758A were identified as having a formulation defect where two (2) times the required amount of antibody was added to Reagent 1B of the kit.

Affected products

Histostain-SP Kit

Lot or serial number

More than 10 numbers, contact manufacturer

Model or catalog number

WA50040A
WA50042A

Companies

Manufacturer
Life Technologies Corp. (Invitrogen)
7335 Executive Way
Frederick
21704
Maryland
UNITED STATES