Device product
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.
Z-2487-2021
Product summary
- Event
- Event 88578
- Status
- Terminated
- Classification
- Class II
- Quantity
- 127
- Official record key
device-enforcement:Z-2487-2021
Official wording
Reason: The product indicated is contaminated with a plasmid DNA that contains the target SARS-CoV-2 sequences.
Code information: 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.
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.
Derived failure modes
-
Unknown
The product indicated is contaminated with a plasmid DNA that contains the target SARS-CoV-2 sequences.