SARS-CoV-2 Process Control (Pellet) - 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.
Recall
- Recall Number
- Z-2486-2021
- Event Number
- 88577
- Firm
- Microbiologics Inc
- FEI Number
- 2150138
- Product Code
- OHQ
- Status
- Terminated
- Root Cause
- Material/Component Contamination
- Initiated
- August 20, 2021
- Terminated
- January 12, 2023
- Address
- 200 Cooper Ave N, Saint Cloud, MN, 56303-4440
Description
SARS-CoV-2 Process Control (Pellet) - 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.
The SARS-CoV-2 Process Control (Pellet) contains RNA transcripts that include diagnostically relevant SARS-CoV-2 targets (CDC and WHO consensus sequences).
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 [email protected] 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 [email protected] with questions or concerns. Collect calls may be made.
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.
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