Reported Sep 29, 2021 · Terminated
SARS-CoV-2 Process Control (Swab) - Product Usage: intended for use as an external, non-viable control material to…
Microbiologics Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Microbiologics Inc · 200 Cooper Ave N · Saint Cloud, MN · 56303-4440
Is this the product you have?
- SARS-CoV-2
- Process Control (Swab) - Product Usageintended for use as an external, non-viable control material to evaluate the performance of nucleic acid tests that detect SARS-CoV-2 virus
- Lot codes and dates
Catalog # HE0063S Lot #'s: HE0063-100-1HE0063-103-2HE0063-103-3HE0063-103-1HE0063-104-1HE0063-101-1 and HE0063-100-1
- Amount recalled
- 127
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was recalled
The product indicated is contaminated with a plasmid DNA that contains the target SARS-CoV-2 sequences.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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