BioFire Diagnostics, LLC recalls BIOFIRE FILMARRAY Pneumonia Panel plus, REF: RFIT-ASY-0143
Pneumonia panels have an increased risk of control failures due to an issue in the manufacturing process, which could lead to delayed results for the customer.
Read the official notice →- Date
- 2024-08-28
- Country
- United States
- Brand
- BioFire Diagnostics
- Product
- BIOFIRE FILMARRAY Pneumonia Panel plus, REF: RFIT-ASY-0143
- Classification
- Class II
- Units
- Worldwide - US Nationwide distribution in the states of WV, IN, AL and the…
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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 BioFire Diagnostics recalls
- 2025-06-04
USBioFire Diagnostics, LLC recalls BioFire Respiratory Panel 2.1 plus Kit, REF: 423740, For Filmarray systems
Due to manufacturing error, respiratory panel may result in elevated control failures and/or false negative results.
FDA · DeviceBioFire Diagnostics, LLCInternational distribution in the country of Singapore.Official notice →- 2025-04-16
- US
BioFire Diagnostics, LLC recalls FilmArra Pneumonia Panel plus (Pneumoplus), REF: RFIT-LBL-0374
Increased risk of control failures and false negative test results with multiplexed nucleic acid test.
FDA · DeviceBioFire Diagnostics, LLCOUS International Distribution to countries of: France, Italia, Spain,…Official notice → - 2024-09-18
- US
BioFire Diagnostics, LLC recalls FILMARRAY 2.0 INSTRUMENT, REF: FLM2-ASY-0001, FLM2-ASY-0001-W
Some automated in vitro diagnostic modules and instruments manufactured or serviced between May 2022 and May 2024 were calibrated with internal equipment that may lead modules and instruments to report higher melting…
FDA · DeviceBioFire Diagnostics, LLCWorldwide - US Nationwide distribution including in the states of NC, TX, OH,…Official notice → - 2024-08-14
- US
BioFire Diagnostics, LLC recalls BIOFIRE FILMARRAY Gastrointestinal (GI) Panel REF RFIT-ASY-0116 (30 test kit) BIOFIRE FILMARRAY Gastrointestinal (GI) Panel REF…
Due to increase of false positive Vibrio/Vibrio Cholerae results when using a certain transport medium.
FDA · DeviceBioFire Diagnostics, LLCU.S.: Nationwide - AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL,…Official notice → - 2024-08-07
- US
BioFire Diagnostics, LLC recalls BIOFIRE Blood Culture Identification 2 (BCID2) Panel, REF: RFIT-ASY-0147, for FILMARRAY Systems, when used in conjunction with Culture…
If blood culture identification panel is used in conjunction with specific lots of culture media bottles, then false positive Serratia marcescens results may occur, due to an increased level of non-viable organism from…
FDA · DeviceBioFire Diagnostics, LLCWorldwide - US Nationwide distribution including in the states of FL, IL, KY,…Official notice → - 2024-02-21
- US
BioFire Diagnostics, LLC recalls FilmArray Gastrointestinal (GI) Panel RFIT-ASY-0116 (30 test kit) RFIT-ASY-0104 (6 test kit) Gastrointestinal microorganism multiplex…
Due to potential signals of increased false positive Norovirus results when using the gastrointestinal (GI) panel.
FDA · DeviceBioFire Diagnostics, LLCWorldwide - U.S. Nationwide distribution in the states of AK, AL, AR, AZ, CA,…Official notice →
Other drugs & medical recalls in the United States
- 2024-08-28
- US
Becton Dickinson & Co. recalls BD BACTEC MGIT 960 PZA Kit)- IVD qualitative procedure for susceptibility testing of Mycobacterium tuberculosis, from culture to…
May intermittently produce falsely resistant results for pyrazinamide (PZA) during susceptibility testing of Mycobacterium tuberculosis isolates.
FDA · DeviceBecton Dickinson & Co.Worldwide distribution - US Nationwide and the countries of Argentina,…Official notice → - US
ROi CPS LLC recalls Regard Kit containing the Microtek decanter
Decanters may have pin holes and tears in sterile packaging that cannot be identified visually.
- US
Ortho-Clinical Diagnostics, Inc. recalls The VITROS XT Chemistry Products ALB-TP Slides is a single device that contains both an albumin test and a total protein test…
The reason for this recall is QuidelOrtho has determined that during normal use the VITROS XT ALB-TP Slides may shed dust and debris as they travel through the MicroSlide Subsystem of the VITROS XT 3400 or VITROS XT…
FDA · DeviceOrtho-Clinical Diagnostics, Inc.Nationwide. Foreign: Australia Belgium Bermuda Brazil Canada L3R 0B8 Chile…Official notice → - US
Abbott Laboratories recalls Alinity hq Analyzer, REF: 09P68-01
1)If Complete Blood Count with differential and reticulocyte(CBC+Diff+Retic) sample is run, then immediately following on same rack CBC+Diff sample is run, then falsely low red blood cell count may occur, generating…
FDA · DeviceAbbott LaboratoriesWorldwide - US Nationwide distribution in the states of NY, OK, NC and the…Official notice → - US
Alcon Research LLC recalls Product Desc: Product Name: CLEARCUT SB INTREPID 2.2 ANG Model/Catalog Number: 8065992561 Software Version: N/A Product Description:…
Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Dual Bevel Sideport and A-OK Comeal/Scleral V-Lance Ophthalmic knives.
FDA · DeviceAlcon Research LLCDomestic: Nationwide Distribution Countries Affected: Argentina, Australia,…Official notice → - US
Ventana Medical Systems, Inc. recalls Ventana anti-CD10 (SP67) Rabbit Monoclonal Primary Antibody, REF: 790-4506, IVD
Their is a potential for high background and off-target staining when using the monoclonal primary antibody which can result in false positive results.
FDA · DeviceVentana Medical Systems, Inc.Worldwide - US Nationwide distribution including in the states of AK, AL, AR,…Official notice →