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…
Read the official notice →- Date
- 2024-09-18
- Country
- United States
- Brand
- BioFire Diagnostics
- Product
- FILMARRAY 2.0 INSTRUMENT, REF: FLM2-ASY-0001, FLM2-ASY-0001-W
- Classification
- Class II
- Units
- Worldwide - US Nationwide distribution including in the states of NC, TX, OH,…
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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
- 2025-12-03
USBioFire Diagnostics, LLC recalls BioFire Respiratory Panel 2.1, IVD, REF: 423742 (30 test kit)
Due to unintended movement of pouch chemistry, nucleic acid test may result in elevated risk of false negative results and risk of control failures.
FDA · DeviceBioFire Diagnostics, LLCUS:AZ, FL,GA,ID NC, NH, NJ, NY, OR, PA, SC OUS: NoneOfficial notice →- 2025-06-04
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BioFire 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
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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 → - 2024-08-28
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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.
FDA · DeviceBioFire Diagnostics, LLCWorldwide - US Nationwide distribution in the states of WV, IN, AL and the…Official notice → - 2024-08-14
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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 →
Other drugs & medical recalls in the United States
- 2024-09-18
- US
Medtronic Perfusion Systems recalls Medtronic DLP Single Stage Venous Cannulae with right angle metal tip, REF 67312
During manufacturing, DLP Single Stage Venous Cannulae - straight tip (Model 66118) was incorrectly placed into a product labeled as DLP Single Stage Venous Cannulae - right angle metal tip (Model 67312).
FDA · DeviceMedtronic Perfusion SystemsWorldwide distribution - US Nationwide and the countries of Cambodia, Greece,…Official notice → - US
Hitachi America, Ltd., Particle Therapy Division recalls Brand Name: PROBEAT Product Name: PROBEAT-FR Model/Catalog Number: N/A Software Version: N/A Product…
During positioning within the system's 3D to 3D matching mode while transferring CBCT images, when the Float Image Selection button is pressed, it may display CBCT images that are insufficient in number.
FDA · DeviceHitachi America, Ltd., Particle Therapy DivisionU.S. Nationwide distribution in the states of TN, TX, and WA.Official notice → - US
Fresenius Medical Care Holdings, Inc. recalls Blood Pressure Module BPM3 TM-2917B (Spare Part Numbers 191378 or 191389) with firmware version S005 installed in 2008…
Machines equipped with BPM3 Blood Pressure Modules (Blood pressure monitor TM-2917B with firmware version S005) will not record Blood Pressure measurements and does not alarm if the cuff tubing is kinked close to the…
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MEDLINE INDUSTRIES, LP - Northfield recalls Medline convenience kits containing semi-rigid suction liners labeled as follows: a) AMB VITRECTOMY, Pack Number DYNJ59921B;…
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FDA · DeviceMEDLINE INDUSTRIES, LP - NorthfieldWorldwide distribution - US Nationwide and the countries of Canada, Panama.Official notice → - US
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Due to reported adverse events, Medline Industries, LP. is issuing a recall on specific SKUs and lots of 1500 cc semi-rigid liners manufactured from 09/2023-11/2023 due to the potential loss of suction or low suction…
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Siemens Healthcare Diagnostics, Inc. recalls Atellica IM CA 19-9 (50 Test)-In vitro diagnostic use in the quantitative measurement of the CA 19-9 tumor-associated…
Positive bias for some samples around the CA 19-9 upper limit of normal of 35 U/m as compared to the previous lot. The sample bias observed was greatest in the Asia Pacific sample population. The observed bias is not…
FDA · DeviceSiemens Healthcare Diagnostics, Inc.Worldwide - US Nationwide distributionOfficial notice →