Microbiologics recalls SARS-CoV-2 Process Control Swabs contaminated with plasmid DNA containing SARS-CoV-2 sequences. These swabs may cause false positive results in nucleic acid tests.
The product indicated is contaminated with a plasmid DNA that contains the target SARS-CoV-2 sequences.
Microbiologics is recalling SARS-CoV-2 Process Control Swabs that contain plasmid DNA with SARS-CoV-2 sequences. This contamination could lead to false positive results in viral tests, potentially causing unnecessary testing or confusion.
The swabs contain plasmid DNA with SARS-CoV-2 sequences, which can cause false positive results in nucleic acid tests. This contamination may lead to incorrect test outcomes and unnecessary follow-up testing.
Users of these swabs for nucleic acid testing may be affected. Laboratory personnel and healthcare providers using the swabs for quality control are most at risk.
Check for catalog number HE0063S and lot numbers HE0063-100-1, HE0063-103-2, HE0063-103-3, HE0063-103-1, HE0063-104-1, HE0063-101-1. These swabs are intended for use as external non-viable control materials in nucleic acid tests.
Identify if your swab has catalog number HE0063S and lot numbers listed above.
The swabs contain plasmid DNA with SARS-CoV-2 sequences, which can cause false positive results in nucleic acid tests.
Check the lot numbers and catalog number to see if your swab is affected. If it is, contact Microbiologics for further instructions.
The swabs are not safe for use as intended because they may cause false positive results in nucleic acid tests.
We’ve drafted a message you can send Microbiologics to request your refund or repair — edit it as you like.
Subject: Recall Z-2487-2021 — Microbiologics Microbiologics Hello, I own a Microbiologics that is covered by recall Z-2487-2021 from Microbiologics. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
