Drugs & medicalClass II

Ortho-Clinical Diagnostics, Inc. recalls VITROS Immunodiagnostic Products High Sample Diluent A Reagent Pack

Lower than expected results for VITROS¿ Immunodiagnostic Products TSH Reagent Pack when diluted with VITROS¿ Immunodiagnostic Products High Sample Diluent A Reagent Pack Lot 2190.

Read the official notice →
Date
2022-01-26
Country
United States
Brand
Ortho-Clinical Diagnostics
Product
VITROS Immunodiagnostic Products High Sample Diluent A Reagent Pack
Classification
Class II
Units
Worldwide distribution - US Nationwide distribution in the states of AL, AR,…
Category
Drugs & medical
Source
FDA · Device

Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer

What to do

  1. Check the product name, strength and lot number against the official notice.
  2. Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
  3. Ask the pharmacy or supplier about a replacement or refund.

General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.

More Ortho-Clinical Diagnostics recalls

  1. 2022-09-14
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    Ortho-Clinical Diagnostics, Inc. recalls VITROS XT 7600 Integrated System with Version 3.7.2 and below Product Code: 6844461

    Performing a system shutdown on VITROS XT 3400 and VITROS XT 7600 Systems may cause a positive or negative shift in the electrical current supplied to the LED used in conjunction with the Digital Imaging Reflectometer.…

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  3. 2022-07-20
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    On-Analyzer Stability (OAS) time, supported for 6 weeks; not 8 weeks as is currently stated in the Instructions For Use (IFU).

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  5. 2022-05-25
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    Ortho-Clinical Diagnostics, Inc recalls VITROS Immunodiagnostic Products LH Reagent Pack Product Code: 1350198

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    FDA · DeviceOrtho-Clinical Diagnostics, IncWorldwide Distribution: US (Nationwide) OUS (Foreign): Australia Bermuda…Official notice →
  7. 2022-03-16
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    Ortho-Clinical Diagnostics, Inc. recalls VITROS Chemistry Products VersaTips, Catalog No. 6801715 A VersaTip sales unit is composed of 1000 tips per box.

    The lot has a shape deformity which may lead to a 16% reduction in the volume of the sample or reagent dispensed. In cases where the error is not detected and the affected results are not suppressed, clinical impact…

    FDA · DeviceOrtho-Clinical Diagnostics, Inc.Domestic distribution nationwide. Foreign distribution to Canada.Official notice →
  9. 2021-11-24
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    Ortho-Clinical Diagnostics, Inc. recalls VITROS Immunodiagnostic Products Anti-HBc IgM Controls, Product Code 6801427 For use in monitoring the performance of the VITROS…

    Ortho Clinical Diagnostics confirmed a complaint that some VITROS Immunodiagnostic Products Anti-HBc IgM Controls Lot 1690 Controls Values booklet contained information for the incorrect product. While the accuracy of…

    FDA · DeviceOrtho-Clinical Diagnostics, Inc.US (Domestic) distribution to states of: AZ, CA, CO, CT, FL, GA, LA, MA, MO,…Official notice →
  11. 2021-10-27
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    VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Quantitative Controls Outside of Expected Control Range, potential for delayed results

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