Microbiologics Inc Recall 88578
Description: SARS-CoV-2 Process Control (Swab) - 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 88578 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-2487-2021 |
| Event ID | 88578 |
| Event Description | SARS-CoV-2 Process Control (Swab) - 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 | 127 |
| Recall Reason | The product indicated is contaminated with a plasmid DNA that contains the target SARS-CoV-2 sequences. |
| Device Classification | 20210929 |
| Device Code Info | Catalog # HE0063S Lot #'s: HE0063-100-1, HE0063-103-2, HE0063-103-3, HE0063-103-1, HE0063-104-1, HE0063-101-1 and HE0063-100-1. |
| Center Classification Date | 20210917 |
| Recall Initiation Date | 20210820 |
| Recalling Firm | Microbiologics Inc |
| Initial Notification | |
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