Health product recall

Bond Wash Solution

Last updated

Summary

Product
Bond Wash Solution
Issue
Medical devices - Device compatibility
What to do

Contact the manufacturer if you require additional information. 

Audience
Healthcare

Affected products

Affected products Lot or Serial number Model or Catalogue number
Bond Wash Solution BATCH: BW102621 AR9590

Issue

Leica Biosystems recently received a complaint for cloudy bond wash, batch bw102621. The IFU states that turbidity of the solution indicates contamination and/or instability of the diluted wash solution. The functional testing was rerun and passed, however, the retain unit at working strength also exhibited cloudiness. This recall is to inform customers of the potential for this issue and to recommend that if the product has been used, the facility should determine whether a review of past results using the affected lot is clinically warranted and discard remaining unused units of this lot.

Recall start date: May 16, 2022

Additional information

Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Pathology
Companies

Leica Biosystems Newcastle Ltd.

Balliol Business Park West, Newcastle Upon Tyne, Tyne And Wear, Great Britain, NE12 8EW

Published by
Health Canada
Audience
Healthcare
Recall class
Type III
Identification number
RA-64206

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