Luminex Corporation recalls VERIGENE Clostridium difficile Nucleic Acid Test, REF 30-002-022
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…
Read the official notice →- Date
- 2023-07-05
- Country
- United States
- Brand
- Luminex
- Product
- VERIGENE Clostridium difficile Nucleic Acid Test, REF 30-002-022
- Classification
- Class II
- Units
- Worldwide and US Nationwide Distribution
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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
- 2025-04-25
PL
EUFixed lamp (LUMINEX) · RENO
A live wire is in contact with the metal casing of the lamp. The user could touch accessible live parts and receive an electric shock. The product does not comply with the requirements of the Low Voltage Directive, nor…
- 2024-08-14
USLuminex 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 →- 2023-12-13
- US
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.
FDA · DeviceLuminex CorporationWorldwide - US Nationwide distribution in the states of AZ, CA, CO, DE, FL,…Official notice → - 2022-11-02
- US
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…
FDA · DeviceLuminex CorporationU.S. Nationwide distribution in the states of NE, TX, MS, TN, KY, ME, CA.Official notice → - 2022-07-13
- US
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.
FDA · DeviceLuminex CorporationWorldwide distribution - US Nationwide and the countries of Kuwait, Austria,…Official notice →
Other drugs & medical recalls in the United States
- 2023-07-05
- US
Medtronic Neuromodulation recalls Vanta with AdaptiveStim Implantable Neurostimulator, Model 977006; spinal chord stimulation
A cardioversion procedure may damage the electronics in the Vanta INS device, making the INS unresponsive and non-functional. As of April 19, 2023, Medtronic has received a total of two complaints concerning this issue…
- US
Hologic, Inc recalls Sertera 14 Gauge Biopsy Device-intended to obtain percutaneous core biopsy samples from soft tissue and tumors of the breast REF: SERTERA-14
The inner needle of the Sertera device is either detaching or discharging and may cause delay in surgery
- US
DRE Medical Group Inc recalls Philips Respironics V60 Ventilator-Intended to mechanically control or assist patient breathing by delivering a predetermined percentage…
Devices were imported with Japanese Language and NIST Oxygen Gas Fittings and retrofitted, may pose a serious health risk as the gas pathway of these devices may be contaminated.
- US
Randox Laboratories Ltd. recalls Immunoassay Premium Level 3-In vitro diagnostic use, as assayed quality control material to monitor the accuracy and reproducibility of…
Delay in reporting results due to Quality Controls running high outside of range. Target value and range for ACTH in Immunoassay Premium Level 3, IA2640, lot 2031EC and Immunoassay Premium Control Tri Level kit batch…
- US
Tornier, Inc recalls AEQUALIS FLEX REVIVE Assembly Screw 0mm Short, Model Number ARS655118
A comingle/swap resulted in the labeling and laser marking on the product to state it is a Aequalis Flex Revive Assembly Screw 0mm Standard (ARS655101) but it was a Aequalis Flex Revive Assembly Screw 0mm Short…
FDA · DeviceTornier, IncWorldwide distribution - US Nationwide and the countries of Australia, Canada,…Official notice → - US
Limacorporate S.p.A recalls REF 1975.14.800, Prima TT Genoid Modular Reverse TT Baseplate, Sterile R
Due to manufacturing issue, their is a potential for peripheral holes to be out of specification.
FDA · DeviceLimacorporate S.p.AUS Nationwide distribution in the states of MI, IL, ND, MO, OK.Official notice →