Ortho Clinical Diagnostics recalls VITROS Anti-SARS-CoV-2 IgG Reagent Packs due to potential false negatives or delayed results from swapped bottles. Affected lots 0010-0013.
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.
Ortho Clinical Diagnostics is recalling VITROS Anti-SARS-CoV-2 IgG Reagent Packs that may cause false negative or delayed test results if reagent bottles are swapped. This could lead to incorrect COVID-19 test outcomes.
The reagent bottles in the pack may be swapped, causing calibration failures or quality control issues. This can result in false negative results or delayed test outcomes when used for COVID-19 testing.
Laboratory professionals and healthcare facilities using the VITROS Anti-SARS-CoV-2 IgG Reagent Packs with catalog number 6199919 and UDI 10758750033355. Those using the affected lots (0010-0013) are most at risk.
Check for catalog number 6199919 and unique device identifier (UDI) 10758750033355. The affected lots are 0010 through 0013.
Identify the lot number on the reagent pack; affected lots are 0010-0013.
The reagent bottles may be swapped within the pack, leading to false negative results or delayed test outcomes due to calibration or quality control failures.
Check the lot number; if it's 0010-0013, contact Ortho Clinical Diagnostics for instructions.
The recall record does not specify a remedy or fix.
We’ve drafted a message you can send Ortho Clinical Diagnostics to request your refund or repair — edit it as you like.
Subject: Recall Z-2771-2020 — Ortho Clinical Diagnostics Ortho Clinical Diagnostics Hello, I own a Ortho Clinical Diagnostics that is covered by recall Z-2771-2020 from Ortho Clinical Diagnostics. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
