RecallGuide.ca
    Medical devicesUpdated Jan 3, 2026VITROSOfficial source

    VITROS ECI Immunodiagnostic Products Vitamin B12 Reagent Pack recall in Canada

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    In plain language

    This recall involves VITROS ECI Immunodiagnostic Products Vitamin B12 Reagent Pack Controls & CA sold in Canada. It's being recalled because some reagent packs may have calibration failures. Stop using the product and follow the return steps in the official notice.

    What to do

    • Stop using the product immediately.
    • Check lot number 2601.
    • Contact Ortho Clinical Diagnostics for return instructions.

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    Affected products

    • VITROS ECI Immunodiagnostic Products Vitamin B12 Reagent Pack Controls & CA

      Model: 145 3489

      Lot: 2601

    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: 2601

    3. 3

      Check the model number

      Model numbers are typically on the product label or packaging.

      Affected models: 145 3489

    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 VITROS ECI Immunodiagnostic Products Vitamin B12 Reagent Pack Controls & CA sold in Canada. It's being recalled because some reagent packs may have calibration failures. Stop using the product and follow the return steps in the official notice.

    What should consumers do?

    Stop using the product immediately. Check lot number 2601. Contact Ortho Clinical Diagnostics for return instructions.

    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 September 17, 2018.

    Is the VITROS brand affected by this recall?

    Yes, VITROS products are affected by this recall. This recall involves VITROS ECI Immunodiagnostic Products Vitamin B12 Reagent Pack Controls & CA sold in Canada. It's being recalled because some reagent packs may have calibration failures. Stop using the product and follow the return steps in the official notice.