Ortho Clinical Diagnostics: The reagent bottles may be swapped within the reagent pack, which may lead to false negative results or delayed results due to calibration failures, or quality control failures.

Agency Publication Date: August 7, 2020

Affected Products

Product: VITROS Anti-SARS-CoV-2 Total Reagent, COV2TOT, VITROS CoV2T. Catalog number 6199922, UDI 10758750033386 - Product Usage: Rx ONLY. For in vitro diagnostic and Laboratory Professional use. For emergency authorization use only.

Lots 0010-0037

Product: VITROS Anti-SARS-CoV-2 IgG Reagent Pack, COV2IgG, VITROS CoV2G. Catalog number 6199919, UDI 10758750033355 - Product Usage: Rx ONLY. For in vitro diagnostic and Laboratory Professional use. For emergency authorization use only.

Lots 0010 - 0013

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 86038

Status: Resolved

Manufacturer: Ortho Clinical Diagnostics

Manufactured In: United States

Units Affected: 2 products (47,271 sales units; 2349 sales units)

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Affected Products

Lots 0010-0037

Lots 0010 - 0013