Reported Aug 19, 2020 · Terminated
VITROS Anti-SARS-CoV-2 IgG Reagent Pack, COV2IgG, VITROS CoV2G. Catalog number 6199919, UDI 10758750033355 - Product…
Ortho Clinical Diagnostics
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Ortho Clinical Diagnostics · 100 Indigo Creek Dr · Rochester, NY · 14626-5101
Is this the product you have?
VITROS Anti-SARS-CoV-2 IgG Reagent PackCOV2IgGVITROS CoV2G. Catalog number 6199919
- UDI 10758750033355 - Product UsageRx ONLY. For in vitro diagnostic and Laboratory Professional use. For emergency authorization use only
- Lot codes and dates
- Lots 0010 - 0013
- Amount recalled
- 2349 sales units
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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