BOND Polymer Refine Detection (2019-11-14)

Starting date:

November 14, 2019

Posting date:

December 6, 2019

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type II

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-71808

Last updated: 2019-12-06

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  Reason
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  Affected products

Affected Products

BOND Polymer Refine Detection

Reason

Leica Biosystems recently became aware that the affected devices were held out of refrigerated storage longer than specified. The maximum temperature the affected devices reached is unknown and may not be covered by the product stability data held by Leica Biosystems newcastle. It is therefore possible that over the course of its shelf life the product might exhibit suboptimal staining. As a precaution, Leica Biosystems newcastle has decided to voluntarily recall the affected lot.

Affected products