SARS-CoV-2 Process Control (Microbiologics) – RNA Transcript Issue (2021)
Contaminated control material can potentially affect diagnostic test performance.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
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.
Brand
Microbiologics Inc
Lot Codes / Batch Numbers
Catalog # HE0062S Lot #'s: HE0062-01-1, HE0062-01-2, HE0062-03-1, HE0062-04-1, HE0062-04-2, HE0062-05-1, HE0062-05-2, HE0062-06-1 and HE0062-06-2
Products Sold
Catalog # HE0062S Lot #'s: HE0062-01-1, HE0062-01-2, HE0062-03-1, HE0062-04-1, HE0062-04-2, HE0062-05-1, HE0062-05-2, HE0062-06-1 and HE0062-06-2
Microbiologics Inc is recalling SARS-CoV-2 Process Control (Pellet) - Product Usage: intended for use as an external, non-viable con due to The SARS-CoV-2 Process Control (Pellet) contains RNA transcripts that include diagnostically relevant SARS-CoV-2 targets (CDC and WHO consensus sequen. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
The SARS-CoV-2 Process Control (Pellet) contains RNA transcripts that include diagnostically relevant SARS-CoV-2 targets (CDC and WHO consensus sequences).
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026