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Microbiologics Inc recalls SARS-CoV-2 Process Control (Pellet) - Product Usage: intended for use as an external, non-viable control material to eva
Recalled September 29, 2021 · FDA recall Z-2486-2021 · Microbiologics
Hazard
The SARS-CoV-2 Process Control (Pellet) contains RNA transcripts that include diagnostically relevant SARS-CoV-2 targets (CDC and WHO consensus sequences). · FDA Class II
Units
218
Sold at
Worldwide distribution - US Nationwide distribution in the states of CA, FL, GA, IL, MD, MT, MN, NC, NY, NV, OR, TN, TX,UT, WA and WI. The countries of Austria, Canada, Colombia, France, Germany, Hong Kong, India, Ireland, Italy, Japan and United Kingdom.
Description
The SARS-CoV-2 Process Control (Pellet) contains RNA transcripts that include diagnostically relevant SARS-CoV-2 targets (CDC and WHO consensus sequences).
Product
SARS-CoV-2 Process Control (Pellet) - Product Usage: intended for use as an external, non-viable control material to evaluate the performance of nucleic acid tests that detect SARS-CoV-2 virus.
Manufacturer(s)
Microbiologics Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →