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Cic-c1q - circulating immune complexes (cic) elisa

Official notice

30 Jan 2025

Last checked

30 Jan 2025

Critical riskHealth Canada

An official Health Canada notice concerns Cic-c1q - circulating immune complexes (cic) elisa. In-house testing with CIC lot 3836 has revealed unexpectedly elevated values in internal control serum samples exceeding the expected target range. Notably, samples with target values below 5 μg eq/ml showed increased results of up to 50% above their target hence, values of samples around the recommended cut-off (5 μg eq/ml) obtained with this lot could incorrectly exceed the true value of the sample, and thus potentially lead to inaccurate conclusions. Recall start date: January 17, 2025 Published 2025-01-30.

What to do now

Contact the manufacturer if you require additional information.

Recall number

76883

Official notice

2025-01-30

The hazard

In-house testing with CIC lot 3836 has revealed unexpectedly elevated values in internal control serum samples exceeding the expected target range. Notably, samples with target values below 5 μg eq/ml showed increased results of up to 50% above their target hence, values of samples around the recommended cut-off (5 μg eq/ml) obtained with this lot could incorrectly exceed the true value of the sample, and thus potentially lead to inaccurate conclusions. Recall start date: January 17, 2025

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

3836, could

Recall Numbers

76883

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Affected products

Product 1

Affected products - CIC-C1q - Circulating Immune Complexes (CIC) ELISA, Lot or serial number - 3836, Model or catalog number - EK-CIC

Risk / hazard

In-house testing with CIC lot 3836 has revealed unexpectedly elevated values in internal control serum samples exceeding the expected target range. Notably, samples with target values below 5 μg eq/ml showed increased results of up to 50% above their target hence, values of samples around the recommended cut-off (5 μg eq/ml) obtained with this lot could incorrectly exceed the true value of the sample, and thus potentially lead to inaccurate conclusions. Recall start date: January 17, 2025

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: Buhlmann Laboratories, Cic-c1q - Circulating Immune Complexes Elisa.

Source & status

Source

Health Canada

Tier

official

Category

HOME

Classification

Type II

App estimate

critical

Recall details

Recall number

76883

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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