No image published for this recall

No image published for this recall

Bond wash solution

Official notice

30 May 2022

Last checked

30 May 2022

Medium riskHealth Canada

An official Health Canada notice concerns Bond wash solution. 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 Published 2022-05-30.

What to do now

Contact the manufacturer if you require additional information.

Recall number

64206

Official notice

2022-05-30

The hazard

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

How to check if you're affected

Compare the product name and identifiers below with the item you own. Follow the official notice if they match.

Lots

is

Recall Numbers

64206

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Affected products

Product 1

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

Risk / hazard

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

Where it was sold

The source does not list specific retailers. See the official notice for where affected products were sold.

Location 1

CA · Canada

Affected area 1

CA · Canada

Company & contacts

Manufacturer

Not provided

Phone

Not provided

Brand: Leica Biosystems Newcastle, Bond Wash Solution.

Source & status

Source

Health Canada

Tier

official

Category

HOME

Classification

Type III

App estimate

medium

Recall details

Recall number

64206

Classification

Type III

Source tier

official

Documents, notices & source

See the official notice and source documents for full details.

View full official notice
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