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Alinity m system
Official notice
23 Dec 2022
Last checked
23 Dec 2022
An official Health Canada notice concerns Alinity m system. Abbott has identified three potential issues which may have impacted the amplification detection unit(s) (ADU) installed on your Alinity M system. 1. Systems which had their ADU's serviced may have an incorrect boardvalue (calibration data file) referenced causing a misconfiguration of the calibration. 2. Inability of maintenance and diagnostics 2300 (amp detect optical calibrations) to recognize error handling and thermal hold errors during the calibration process, potentially leading to a misconfiguration of the calibration. 3. Under specific conditions during the adu manufacturing process, an incorrect calibration may potentially have been configured. Recall start date: December 13, 2022 Published 2022-12-23.
What to do now
Contact the manufacturer if you require additional information.
Recall number
72407
Official notice
2022-12-23
The hazard
The hazard
Abbott has identified three potential issues which may have impacted the amplification detection unit(s) (ADU) installed on your Alinity M system. 1. Systems which had their ADU's serviced may have an incorrect boardvalue (calibration data file) referenced causing a misconfiguration of the calibration. 2. Inability of maintenance and diagnostics 2300 (amp detect optical calibrations) to recognize error handling and thermal hold errors during the calibration process, potentially leading to a misconfiguration of the calibration. 3. Under specific conditions during the adu manufacturing process, an incorrect calibration may potentially have been configured. Recall start date: December 13, 2022
How to check if you're affected
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
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Affected products
Product 1
Risk / hazard
Where it was sold
Where it was sold
The source does not list specific retailers. See the official notice for where affected products were sold.
Location 1
Affected area 1
Company & contacts
Company & contacts
Brand: Abbott Molecular, Alinity M System.
Source & status
Source & status
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Tier
Category
Classification
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Recall details
Recall details
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Classification
Source tier
Documents, notices & source
See the official notice and source documents for full details.
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