Recall Z-2486-2021— Microbiologics Inc
Class II · Terminated
Class II FDA medical device recall by Microbiologics Inc, initiated 2021-08-20, terminated 2023-01-12. FDA's recall record names no specific 510(k) clearance for this event. 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.. Reason: The SARS-CoV-2 Process Control (Pellet) contains RNA transcripts that include diagnostically relevant SARS-CoV-2 targets (CDC and WHO consensus sequences)..
- Recalling firm
- Microbiologics Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2021-08-20
- Terminated
- 2023-01-12
- Firm location
- Saint Cloud, MN, United States
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).
Data sourced from openFDA. This site is unofficial and independent of the FDA.