Luminex Corporation recalls Verigene Processor SP, Model Numbers: 10-0000-07 and 10-0000-07-R
Two of three complaints were initiated due to the customers repeatedly obtaining No Call results on the Processor SPs in question.
Read the official notice →- Date
- 2022-04-20
- Country
- United States
- Brand
- Luminex
- Product
- Verigene Processor SP, Model Numbers: 10-0000-07 and 10-0000-07-R
- Classification
- Class II
- Units
- US: TX, CT, LA
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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
- 2022-08-24
USLuminex 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 → - 2022-05-25
- US
Luminex Corporation recalls VERIGENE Nucleic Acid Test Kit-BC-GN Extraction Tray - 9.73 mL, REF 20-009-021
Higher than normal "No Call Internal Control failures" due to a missing reagent within a small subset of the extraction tray lot.
- US
Luminex Corporation recalls Verigene Processor SP, Models 10-0000-07/10-0000-07R a component of the Verigene system
Heater within the Verigene System may be outside of established temperature limits for assays which could result in false negative results.
FDA · DeviceLuminex CorporationUS:OH, ME, PA, FL, IL, NE, IN, TX, GA, WA, MI, CO, AZ, OH, KY, CA, VT OUS: NoneOfficial notice → - 2022-02-09
- US
Luminex Corporation recalls ARIES HSV 1&2 Assay, Catalog/REF# 50-10017
Impacted lot may leak inside the ARIES instrument. Testing confirmed a leak rate of 0.9%. Leaking cassettes could potentially lead to incorrect results or a delay in reporting results due to an Invalid.
FDA · DeviceLuminex CorporationWorldwide distribution - US Nationwide distribution in the states of New…Official notice → - 2022-01-26
- US
Luminex Corporation recalls ARIES HSV 1&2 Assay, Part Number/REF 50-10017
Impacted lot may leak inside the ARIES instrument.
FDA · DeviceLuminex CorporationWorldwide distribution - US Nationwide distribution in the states of Alabama,…Official notice →
Other drugs & medical recalls in the United States
- 2022-04-20
- US
Siemens Healthcare Diagnostics, Inc. recalls Atellica CH Fructosamine (Fruc), Siemens Material Number 11097637
Siemens Healthcare Diagnostics Inc. has confirmed the potential for reagent carryover impacting quality control (QC), patient samples, and calibrator results.
FDA · DeviceSiemens Healthcare Diagnostics, Inc.Global Distribution. US Nationwide.Official notice → - US
Philips North America, LLC recalls The IFU for the Autoclavable Temperature Probes: Part # 453564635891, providing in the packaging for the following product model #s:…
Update to instructions for use regarding the cleaning and disinfection process for the reusable probes.
FDA · DevicePhilips North America, LLCWorldwide distribution: US (nationwide) Including Puerto Rico and OUS…Official notice → - US
Abbott Vascular recalls Plus 30 Priority Pack w/.096 RHV - REF 1000183 WPL2122277-01 (20-03-01) Plus 30 Priority Pack w/.115 RHV - REF 1000185-115 WPL2122279-01…
Due to an increase in complaint trend for leaks and intermittent/loose connections.
FDA · DeviceAbbott VascularU.S Nationwide Distribution.: AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID,…Official notice → - US
GE Healthcare, LLC recalls MUSE Cardiology Information System, Model Numbers: a) 3101011-040, b) 3101010-401, c) 3101010-009, d) 3101010-008
Two scenarios may cause edits to measurements and diagnosis statements can be lost after a test is Signed in the MUSE NX web client.
FDA · DeviceGE Healthcare, LLCUS and Australia, Austria, Bahrain, Belgium, Brazil, Canada, Denmark, England,…Official notice → - US
Sensory Medical Inc recalls Cub 2 Enclosed Bed Canopy System
Due potential misuse of the product, firm is updating warnings and precautions booklet for products distributed before December 16, 2021.
FDA · DeviceSensory Medical IncU.S. Nationwide distribution to states including: AK, AZ, CA, CO, CT, DE, FL,…Official notice → - US
Volcano Corp recalls MM-TSM (Touch Screen Module/Secondary Controller/Bedside Controller), Part Numbers: 300002018101, 300002018102, used with IntraSight…
Multi-Modality Touch Screen Modules (MM-TSM), used with integrated IVUS systems, may crack, or become damaged, which may affect their usability. They could become non-functional. Therefore, bottom protective beams will…
FDA · DeviceVolcano CorpUS: AZ, IL, NV, MI, FL, NC, AK, PA, WI, MN, CA, AR, NJ, TX, OR, NM, SD, CO,…Official notice →