Microbiologics Inc Recall 88577
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.
Microbiologics Inc Recall 88577 Information
| Status | Terminated |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-2486-2021 |
| Event ID | 88577 |
| Event 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. |
| Product Type | Devices |
| 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. |
| Quantity | 218 |
| Recall Reason | The SARS-CoV-2 Process Control (Pellet) contains RNA transcripts that include diagnostically relevant SARS-CoV-2 targets (CDC and WHO consensus sequences). |
| Device Classification | 20210929 |
| Device Code Info | 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 |
| Center Classification Date | 20210917 |
| Recall Initiation Date | 20210820 |
| Recalling Firm | Microbiologics Inc |
| Initial Notification | |
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