Luminex Corporation recalls Luminex VERIGENE BC-GP Utility Tray (5-Pack Carrier), Gram-Positive Blood Culture Nucleic Acid Test, REF 20-011-018, a component of the…
Potentially defective utility trays in the reagent kits.
Read the official notice →- Date
- 2023-12-13
- Country
- United States
- Brand
- Luminex
- Product
- Luminex VERIGENE BC-GP Utility Tray (5-Pack Carrier), Gram-Positive Blood Culture Nucleic Acid Test, REF 20-011-018, a component of the…
- Classification
- Class II
- Units
- Worldwide - US Nationwide distribution in the states of AZ, CA, CO, DE, FL,…
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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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Luminex Corporation recalls Verigene Gram Positive Blood Culture (BC-GP) Nucleic Acid Test
Potential for defective test cartridges which may result in false positive results for the Staphylococcus lugdunensis and Enterococcus faecium targets.
FDA · DeviceLuminex CorporationUS Nationwide distribution including in the states of AZ, CA, CO, DE, FL, GA,…Official notice → - 2023-07-05
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Luminex Corporation recalls VERIGENE Clostridium difficile Nucleic Acid Test, REF 30-002-022
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Luminex Corporation recalls ARIES SARS-CoV-2 Assay, REF: 50-10047
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.
FDA · DeviceLuminex CorporationDistribution US nationwide, Indonesia, and Hong Kong.Official notice → - 2022-08-24
- US
Luminex Corporation recalls ARIES SARS-CoV-2 Assay
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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Other drugs & medical recalls in the United States
- 2023-12-13
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Liberty Medical Solutions, LLC recalls Multi-Mode Stimulator, Transcutaneous Electrical Nerve Stimulation
The instruction manuals that were included with the Multi-Mode Stimulators distributed from 2018 to 2023 did not contain all of the appropriate warnings and contraindications.
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CooperSurgical, Inc. recalls Cooper Surgical H/S ELLIPTOSPHERE CATH 5 Fr -For administering contrast media during Hysterosalpingography or Hysterosonography procedures…
Incorrect bonding material used for assembly of the catheter, may fail, resulting in detachment of component parts, broken components, or leakage. This breakage may result in delay of procedure
FDA · DeviceCooperSurgical, Inc.Nationwide Foreign: BELGIUM CANADA MALAYSIA NETHERLANDS SPAIN SWEDEN SWITZERLANDOfficial notice → - US
Randox Laboratories Ltd. recalls RANDOX Total Bilirubin.
Randox has had reports of elevated patient results using Plasma (lithium heparin) samples with Total Bilirubin reagent (TBil) Vanadate Oxidation Method.
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Integra LifeSciences Corp. recalls Integra Cranial Access Kit - For access to the subarachnoid space or the lateral ventricles of the brain. Catalog Number: INS7040
Defect in the outer packaging of the Cranial Access Kits. can cause the packaging to split without any additional forces outside compromising the sterility of the device
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