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.
- Company
- Microbiologics Inc
- Recall Initiated
- August 20, 2021
- Terminated
- January 12, 2023
- Recall Number
- Z-2487-2021
- Quantity
- 127
- Firm Location
- Saint Cloud, MN
Reason for Recall
The product indicated is contaminated with a plasmid DNA that contains the target SARS-CoV-2 sequences.
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.
Lot / 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.
Root Cause
Material/Component Contamination
Action Taken
On AUGUST 23, 2021 THE FIRM SENT THE FOLLOWING INSTRUCTIONS TO THEIR CONSIGNEES.: INSTRUCTIONS: 1. REVIEW lab procedures to understand how this information affects your usage 2. USE OR DISCARD depending on your lab procedures and how this information affects your usage. 3. COMPLETE the response form provided. 4. RETURN the response form to recall@microbiologics.com 5. KEEP this letter for your records. 6. CONTACT Microbiologics to discuss possible alternatives if replacement is needed Microbiologics is dedicated to ensuring the success of your quality control processes. Please contact our Recall Support team at 320.229.7073 or recall@microbiologics.com with questions or concerns. Collect calls may be made.