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Bd sars-cov-2 reagents for bd max system

Official notice

17 May 2024

Last checked

17 May 2024

Medium riskHealth Canada

An official Health Canada notice concerns Bd sars-cov-2 reagents for bd max system. BD has identified, through an internal investigation, that the BD Max SARS-CoV-2 Assays, may produce false negative results due to decreased activity of the enzyme utilized in the manufacture of this assay's master mix. A review of all products produced with this master mix has been undertaken and no other assays are impacted. Recall Start Date: May 7, 2024 Published 2024-05-17.

What to do now

Review notice & share with users/customers, identify & destroy affected product, complete/return reply form.

Recall number

75530

Official notice

2024-05-17

The hazard

BD has identified, through an internal investigation, that the BD Max SARS-CoV-2 Assays, may produce false negative results due to decreased activity of the enzyme utilized in the manufacture of this assay's master mix. A review of all products produced with this master mix has been undertaken and no other assays are impacted. Recall Start Date: May 7, 2024

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.

Recall Numbers

75530

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Affected products

Product 1

Affected products - BD SARS-CoV-2 Reagents For BD Max System, Lot or serial number - 3291356, Model or catalog number - 445003-01

Risk / hazard

BD has identified, through an internal investigation, that the BD Max SARS-CoV-2 Assays, may produce false negative results due to decreased activity of the enzyme utilized in the manufacture of this assay's master mix. A review of all products produced with this master mix has been undertaken and no other assays are impacted. Recall Start Date: May 7, 2024

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: Becton Dickinson And [bd], Bd Sars-cov-2 Reagents For Bd Max System.

Source & status

Source

Health Canada

Tier

official

Category

HOME

Classification

Type II

App estimate

medium

Recall details

Recall number

75530

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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