Luminex Corporation recalls VERIGENE Enteric Pathogens Nucleic Acid Test, Part No. 30-002-23
There is a potential for false negative results using VERIGENE CDF Stool PREP KIT and VERIGENE EP Stool PREP KIT due to hydrophobic characteristics of the swab.
Read the official notice →- Date
- 2022-07-13
- Country
- United States
- Brand
- Luminex
- Product
- VERIGENE Enteric Pathogens Nucleic Acid Test, Part No. 30-002-23
- Classification
- Class II
- Units
- Worldwide distribution - US Nationwide and the countries of Kuwait, Austria,…
- Category
- Drugs & medical
- Source
- FDA · Device
Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer
What to do
- Check the product name, strength and lot number against the official notice.
- Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
- Ask the pharmacy or supplier about a replacement or refund.
General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.
More Luminex recalls
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It is possible that in rare instances the VERIGENE CDF Nucleic Acid Test Kit (Part No. 20-005-022) and the VERIGENE Enteric Pathogens Nucleic Acid Test Kit (Part No. 20-005-023) could provide a false-negative result…
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A part defect with the wash 1 syringe of an SARS-CoV-2 assay could lead to incomplete extraction thereby producing an invalid or false negative assay result.
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SARS-CoV-2 assay that detects SARS-CoV-2 ORF1ab and N genes may not detect the ORF1ab gene. A positive results if either SARS-CoV-2 genes is detected, but If both genes are mistakenly not detected, a false negative…
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FDA · DeviceLuminex CorporationUS:OH, ME, PA, FL, IL, NE, IN, TX, GA, WA, MI, CO, AZ, OH, KY, CA, VT OUS: NoneOfficial notice → - 2022-04-20
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Other drugs & medical recalls in the United States
- 2022-07-13
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Siemens Medical Solutions USA, Inc recalls syngo Application software VE20 (Material Number 10848815) installed on the Artis pheno and Artis icono systems as follows:…
After CT image data from Toshiba is loaded, image mirroring can occur along the horizontal and vertical image axes. If this error occurs, the patient orientation/position may be misinterpreted and result in…
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Arcoma AB recalls Omnera 400A Digital Radiographic System
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