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Delfia autodelfia pigf 1-2-3

Official notice

7 Jun 2024

MediumHealth Canada

An official Health Canada notice concerns Delfia autodelfia pigf 1-2-3. We have become aware through customer complaints that the measured PlGF analyte concentrations in part of the patient samples (approximately 15%) may be decreased ≥ 50%. The decreased PlGF concentration results may cause raise in the amount of high risk/false positive pre-eclampsia and Down's syndrome screening results. Recall Start Date: May 29, 2024 Published 2024-06-07.

What to do now

Contact the importer REVVITY HEALTH SCIENCES CANADA, INC. At TURKUQMRESPONSE@REVVITY.COM.

Recall number

75641

Official notice

2024-06-07

The hazard

We have become aware through customer complaints that the measured PlGF analyte concentrations in part of the patient samples (approximately 15%) may be decreased ≥ 50%. The decreased PlGF concentration results may cause raise in the amount of high risk/false positive pre-eclampsia and Down's syndrome screening results. Recall Start Date: May 29, 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

75641

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Affected products

Product 1

Affected products - DELFIA / AutoDELFIA PIGF 1-2-3, Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalog number - B055-301

Risk / hazard

We have become aware through customer complaints that the measured PlGF analyte concentrations in part of the patient samples (approximately 15%) may be decreased ≥ 50%. The decreased PlGF concentration results may cause raise in the amount of high risk/false positive pre-eclampsia and Down's syndrome screening results. Recall Start Date: May 29, 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: Wallac, Delfia Autodelfia Pigf 1-2-3.

Source & status

Source

Health Canada

Tier

official

Category

HOME

Classification

Type II

App estimate

medium

Recall details

Recall number

75641

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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