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.
Reported: September 29, 2021 Initiated: August 20, 2021 #Z-2486-2021
Product Description
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.
Reason for Recall
The SARS-CoV-2 Process Control (Pellet) contains RNA transcripts that include diagnostically relevant SARS-CoV-2 targets (CDC and WHO consensus sequences).
Details
- Recalling Firm
- Microbiologics Inc
- Units Affected
- 218
- Distribution
- 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.
- Location
- Saint Cloud, MN
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Microbiologics Inc. Units affected: 218.
Why was this product recalled? ▼
The SARS-CoV-2 Process Control (Pellet) contains RNA transcripts that include diagnostically relevant SARS-CoV-2 targets (CDC and WHO consensus sequences).
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on September 29, 2021. Severity: Moderate. Recall number: Z-2486-2021.
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