Diode Failure Risk Prompts Abbott ARCHITECT i2000SR Module Recall 2026
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Health Canada has published a Type II health product recall, number RA-82800, covering the ARCHITECT ‘I’ System i2000SR Processing Module made by Abbott Laboratories. The notice was posted on October 16, 2026, and lists a recall date of October 7, 2026. It is aimed at healthcare audiences and involves a medical device used in chemistry testing.
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The concern is a 5 Amp diode inside an optional hardware component, the Induction Heater Control Module. Under certain conditions that diode may be exposed to more current than it is rated to handle.
Recalled Products at a Glance
The recall covers one product entry in the Health Canada database. Only ARCHITECT i2000SR Processing Modules fitted with an Induction Heater (IH) Control Module are affected. Units without that optional kit are not part of the issue described in the notice.
- Product: ARCHITECT ‘I’ System – i2000SR Processing Module – Class 4
- Brand and company: Abbott Laboratories, Irving, Texas, United States
- Model or catalogue number: 03M74-02
- Lot or serial number: ISR64041
- Recall number: RA-82800
- Recall class: Type II
- Recall date: 2026-10-07
- Published by: Health Canada
What Triggered the Recall
According to the notice, the 5A diode in the IH Control Module on the ARCHITECT i2000SR IH Kit may be exposed to current above its specified rating. That could lead to component failure.
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If the diode fails, the notice says it could cause localized electrical arcing, damage to the circuit board and the generation of smoke. The issue is classified under the heading Medical devices – Performance.
Health Canada also describes a potential for operator injury and property damage. The risks named are smoke, burns and hot surfaces caused by the excess current on the diode.
Built-In Protections and Reported Outcomes
The notice stresses that the IH Control Module housing is classified as a fire enclosure under International Electrotechnical Commission (IEC) 61010-1. It is designed to contain thermal events.
The protective features listed include flame-retardant circuit board material and a metal fire-rated enclosure. These are intended to help prevent any event from spreading beyond the module.
In every failure observed so far, the damage stayed contained within the IH Control Module. No injuries or property damage have been reported. The notice also states there have been no occurrences of fire and smoke leading to property damage, and no reported cases of operator injury linked to this issue.
Who Should Be Concerned
This alert is directed at the healthcare audience, meaning laboratories and facilities that operate the ARCHITECT i2000SR Processing Module. The affected unit is identified by model 03M74-02 and lot or serial number ISR64041.
Staff responsible for laboratory equipment should check whether any instrument on site has the optional Induction Heater kit installed. The Health Canada listing does not give a number of units affected, and it does not list distribution details beyond the model and lot information above.
What Consumers Need to Do Now
The only action listed in the Health Canada summary is to contact the manufacturer if additional information is required. The notice does not publish a phone number or email address for Abbott, and it does not describe a repair, replacement or refund process.
- Check whether your ARCHITECT i2000SR Processing Module is fitted with an IH Control Module.
- Compare the model number 03M74-02 and lot or serial number ISR64041 against your equipment records.
- Contact Abbott Laboratories for further information about the issue and any next steps.
- Use the official Health Canada recall page for RA-82800 as your reference when contacting the manufacturer.
From the Agency
Health Canada lists the recall as a Type II health product recall and records the issue as a medical device performance problem. The agency’s notice notes the containment features built into the module and repeats that no injuries or property damage have been reported.
Health Canada also provides a way to receive email notifications about new and updated recalls and safety alerts through its recalls and safety alerts website. Anyone who has a health or safety concern about a product can report it through the Government of Canada’s online reporting service.
The notice was last updated on October 16, 2026. Details may change, so users of the affected equipment should refer to the official listing and to the manufacturer for current guidance.
Official Source: View original notice on Health Canada →
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