Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
VITROS Anti-SARS-CoV-2 IgG Reagent Pack Recalled by Ortho Clinical Diagnostics Due to The reagent bottles may be swapped within the...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Ortho Clinical Diagnostics directly.
Affected Products
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.
Quantity: 2349 sales units
Why Was This Recalled?
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.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Ortho Clinical Diagnostics
Ortho Clinical Diagnostics has 22 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report