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Atellica ci system

Official notice

15 Nov 2024

Last checked

15 Nov 2024

Medium riskHealth Canada
Watch Siemens

An official Health Canada notice concerns Atellica ci system. Siemens Healthineers has confirmed through the internal investigation of customer complaints that the IMT diluent volume remaining (% remaining) does not decrease as expected on the Atellica® CI analyzer. The IMT module runs a standard a refresh sequence before processing samples if at least two minutes of inactivity have passed. IMT diluent is used by this sequence, however, the calculated diluent volume is not accurate, potentially leading to the IMT diluent being empty while still displaying that volume is remaining. In this case sodium (Na), potassium (K) and chloride (Cl) test results may be falsely elevated. Quality control materials demonstrate the same behavior. Recall start date: November 6, 2024 Published 2024-11-15.

What to do now

Contact the manufacturer if you require additional information.

Recall number

76514

Official notice

2024-11-15

The hazard

Siemens Healthineers has confirmed through the internal investigation of customer complaints that the IMT diluent volume remaining (% remaining) does not decrease as expected on the Atellica® CI analyzer. The IMT module runs a standard a refresh sequence before processing samples if at least two minutes of inactivity have passed. IMT diluent is used by this sequence, however, the calculated diluent volume is not accurate, potentially leading to the IMT diluent being empty while still displaying that volume is remaining. In this case sodium (Na), potassium (K) and chloride (Cl) test results may be falsely elevated. Quality control materials demonstrate the same behavior. Recall start date: November 6, 2024

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

76514

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Affected products

Product 1

Affected products - Atellica CI System, Lot or serial number - IRC009062411 IRC007512342 IRC009012411, Model or catalogue number - 10947347

Risk / hazard

Siemens Healthineers has confirmed through the internal investigation of customer complaints that the IMT diluent volume remaining (% remaining) does not decrease as expected on the Atellica® CI analyzer. The IMT module runs a standard a refresh sequence before processing samples if at least two minutes of inactivity have passed. IMT diluent is used by this sequence, however, the calculated diluent volume is not accurate, potentially leading to the IMT diluent being empty while still displaying that volume is remaining. In this case sodium (Na), potassium (K) and chloride (Cl) test results may be falsely elevated. Quality control materials demonstrate the same behavior. Recall start date: November 6, 2024

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

Siemens, Atellica Ci System

Manufacturer

Not provided

Phone

Not provided

Brand: Siemens, Atellica Ci System.

Source & status

Source

Health Canada

Tier

official

Category

HOME

Classification

Type II

App estimate

medium

Recall details

Recall number

76514

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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