Z-2486-2021 Class II Terminated
FDA device recall Z-2486-2021 was initiated by Microbiologics Inc on August 20, 2021 and is designated Class II. 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). The recall status is terminated (terminated January 12, 2023). Affected quantity: 218.
Recall Details
- Product Type
- Devices
- Report Date
- September 29, 2021
- Initiation Date
- August 20, 2021
- Termination Date
- January 12, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 218
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).
Distribution Pattern
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.
Code Information
Catalog # HE0062S Lot #'s: HE0062-01-1, HE0062-01-2, HE0062-03-1, HE0062-04-1, HE0062-04-2, HE0062-05-1, HE0062-05-2, HE0062-06-1 and HE0062-06-2