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Aptima® cmv quant assay

Official notice

6 Dec 2023

Last checked

6 Dec 2023

Medium riskHealth Canada
Watch Hologic

An official Health Canada notice concerns Aptima® cmv quant assay. When processing specific patient plasma specimens with the Aptima® CMV Quant Assay, a ML2 error flag may occur, which will invalidate specimens within the assay run. Recall start date: November 20, 2023 Published 2023-12-06.

What to do now

Instructions provided on how to respond.

Recall number

74705

Official notice

2023-12-06

The hazard

When processing specific patient plasma specimens with the Aptima® CMV Quant Assay, a ML2 error flag may occur, which will invalidate specimens within the assay run. Recall start date: November 20, 2023

How to check if you're affected

Compare the VIN on your vehicle against the official list. If your VIN is listed, follow the official notice.

Recall Numbers

74705

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Affected products

Product 1

Affected products - Aptima® CMV Quant Assay, Lot or serial number - Contact the manufacturer., Model or catalog number - PRD-05074

Risk / hazard

When processing specific patient plasma specimens with the Aptima® CMV Quant Assay, a ML2 error flag may occur, which will invalidate specimens within the assay run. Recall start date: November 20, 2023

Where it was sold

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

Location 1

CA · Canada

Affected area 1

CA · Canada

Company & contacts

Brand

Hologic, Aptima® Cmv Quant Assay

Manufacturer

Not provided

Phone

Not provided

Brand: Hologic, Aptima® Cmv Quant Assay.

Source & status

Source

Health Canada

Tier

official

Category

HOME

Classification

Type II

App estimate

medium

Recall details

Recall number

74705

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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