SARS-CoV-2 Process Control recall: Contamination
SARS-CoV-2 Process Control (Swab) - Product Usage: intended for use as an external, non-viable control material to evaluate the performance of nucleic…
Why was SARS-CoV-2 Process Control recalled?
The product indicated is contaminated with a plasmid DNA that contains the target SARS-CoV-2 sequences.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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.
- 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…
- Recalling firm
- Microbiologics Inc
- Quantity
- 127
- 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.
- Recall date
- September 29, 2021
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)