RecallGuide.ca
    Medical devicesUpdated Jan 3, 2026Abbott Laboratories Diagnostics DivisionOfficial source

    Architect "I" System - Stat Myoglobin Assay

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    In plain language

    This recall involves the Architect "I" System - Stat Myoglobin Assay, lot number 166000, sold in Canada. It's being recalled because it is an unauthorized medical device and did not meet acceptance criteria during stability testing. Stop using the product and contact the manufacturer for more information.

    What to do

    • Stop using the product immediately.
    • Check the lot number 166000.
    • Contact Abbott Laboratories Diagnostics Division for additional information.

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    Affected products

    • Architect "I" System - Stat Myoglobin Assay

      Model: 2K43-01

      Lot: 166000

    Do I have this product?

    This recall only applies to specific products. Follow the steps below to check.

    1. 1

      Check the product name

      Make sure your product name matches one of the affected products listed above.

    2. 2

      Check the lot number

      Lot numbers identify specific production batches.

      Affected lots: 166000

    3. 3

      Check the model number

      Model numbers are typically on the product label or packaging.

      Affected models: 2K43-01

    If your product matches one or more of the details above, it may be affected by this recall.

    If your product does not match these details, it is not affected by this recall.

    When in doubt, always check the official notice.

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    Frequently Asked Questions

    Why was this product recalled?

    This recall involves the Architect "I" System - Stat Myoglobin Assay, lot number 166000, sold in Canada. It's being recalled because it is an unauthorized medical device and did not meet acceptance criteria during stability testing. Stop using the product and contact the manufacturer for more information.

    What should consumers do?

    Stop using the product immediately. Check the lot number 166000. Contact Abbott Laboratories Diagnostics Division for additional information.

    Where was the product sold?

    This product was sold in Canada. For specific retailers or distribution areas, please check the official recall notice linked on this page.

    Is there a health risk?

    A potential safety risk has been identified with this product. Stop using it immediately and follow the instructions in the official recall notice.

    When was this product recalled?

    This product was recalled on March 14, 2022.

    Is the Abbott Laboratories Diagnostics Division brand affected by this recall?

    Yes, Abbott Laboratories Diagnostics Division products are affected by this recall. This recall involves the Architect "I" System - Stat Myoglobin Assay, lot number 166000, sold in Canada. It's being recalled because it is an unauthorized medical device and did not meet acceptance criteria during stability testing. Stop using the product and contact the manufacturer for more information.