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Anti-lua (lu1)

Official notice

11 Jul 2022

Last checked

11 Jul 2022

Medium riskHealth Canada

An official Health Canada notice concerns Anti-lua (lu1). A recall was issued in connection to false negative results for the Anti-Lua control (Lu 1) from lot 3113160-00, because minimum antibody levels were not met. The two lots (3131020-00 and 3131030-00) produced to replace lot 3113160-00 have shown a decrease in reactivity over their life of approximately nine months. Soon, the acceptance criteria may no longer be met. Therefore, these lots are also being recalled. Recall start date: Mar 22, 2022 Published 2022-07-11.

What to do now

Contact the manufacturer if you require additional information.

Recall number

64043

Official notice

2022-07-11

The hazard

A recall was issued in connection to false negative results for the Anti-Lua control (Lu 1) from lot 3113160-00, because minimum antibody levels were not met. The two lots (3131020-00 and 3131030-00) produced to replace lot 3113160-00 have shown a decrease in reactivity over their life of approximately nine months. Soon, the acceptance criteria may no longer be met. Therefore, these lots are also being recalled. Recall start date: Mar 22, 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

3113160-00, because

Recall Numbers

64043

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Affected products

Product 1

Affected Products - Anti-Lua (Lu1), Lot or Serial Number - 3131020-00 3113160-00 3131030-00, Model or catalog number - 808 216

Risk / hazard

A recall was issued in connection to false negative results for the Anti-Lua control (Lu 1) from lot 3113160-00, because minimum antibody levels were not met. The two lots (3131020-00 and 3131030-00) produced to replace lot 3113160-00 have shown a decrease in reactivity over their life of approximately nine months. Soon, the acceptance criteria may no longer be met. Therefore, these lots are also being recalled. Recall start date: Mar 22, 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: Bio-rad Medical Diagnostics, Anti-lua.

Source & status

Source

Health Canada

Tier

official

Category

HOME

Classification

Type II

App estimate

medium

Recall details

Recall number

64043

Classification

Type II

Source tier

official

Documents, notices & source

See the official notice and source documents for full details.

View full official notice
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