BioFire Diagnostics, LLC recalls BIOFIRE Blood Culture Identification 2 (BCID2) Panel, REF: RFIT-ASY-0147, used with Maine Molecular Quality Controls, Inc (MMQCI)…
Routine quality control testing of affected blood culture identification panel with affected control panel may need to be amended, due to control panel/instrument characteristic changes, that lead C. tropicalis to be…
Read the official notice →- Date
- 2023-12-13
- Country
- United States
- Brand
- BioFire Diagnostics
- Product
- BIOFIRE Blood Culture Identification 2 (BCID2) Panel, REF: RFIT-ASY-0147, used with Maine Molecular Quality Controls, Inc (MMQCI)…
- Classification
- Class II
- Units
- Worldwide Distribution: US (nationwide): DE, OH, NY, IL, KY, FL, GA, KS, CA,…
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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
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- Check the product name, strength and lot number against the official notice.
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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
- 2024-02-21
USBioFire Diagnostics, LLC recalls BIOFIRE Blood Culture Identification 2 (BCID2) Panel when used with: BD BACTEC Lytic Anaerobic medium BD BACTEC Peds Plus medium BD…
Due to a trend in false positive Candida tropicalis results on blood culture panel when using certain BD BACTEC vial mediums
FDA · DeviceBioFire Diagnostics, LLCWorldwide - U.S. Nationwide distribution including in the states of AK, AL,…Official notice →- 2024-02-14
- US
BioFire Diagnostics, LLC recalls FilmArray Pneumonia Panel Plus (Pneumoplus), REF: RFIT-ASY-0143, CED 2797, IVD, Rx Only (30 test kit)
Their is a potential for false positive results when using Pneumonia panel.
FDA · DeviceBioFire Diagnostics, LLCWorldwide - US Nationwide distribution including in the states of AL, AR, AZ,…Official notice → - 2024-01-17
- US
BioFire Diagnostics, LLC recalls The BIOFIRE Respiratory Panel 2.1 (RP2.1) is a PCR-based multiplexed nucleic acid test intended for use with the BIOFIRE FILMARRAY 2.0…
A manufacturing event may contribute to elevated rates of false negative results while using gastrointestinal panel and respiratory panel, which could lead to inappropriate antibiotic treatment, no treatment, delay of…
FDA · DeviceBioFire Diagnostics, LLCUS: NC, MO, NE, CT, IL, TN, NJ, OH, MA, CA, FL, UT, IA, KS, TX, MDOfficial notice → - 2023-11-29
- US
BioFire Diagnostics, LLC recalls FilmArray TORCH REF HTFA-ASY-0104. HTFA-ASY-0104 is the BIOFIRE TORCH Base which includes barcode scanner, touch screen computer and USB…
Due to an increased risk of degradation of the power entry switch resulting from arcing inside of the power switch that may result in carbon build-up on the switch contacts. The carbon build-up may lead to excess…
FDA · DeviceBioFire Diagnostics, LLCWorldwide - U.S. Nationwide distribution including in the states of AK, AL,…Official notice → - 2023-09-20
- US
BioFire Diagnostics, LLC recalls FILMARRAY Gastrointestinal (GI) Panel (Part No.: RFIT-ASY-0104 & RFIT-ASY-0116) Pouch Module Software
The firm has identified an increased risk of obtaining false positive Cryptosporidium results from customers using the BIOFIRE¿ FILMARRAY¿ Gastrointestinal (GI) Panel
FDA · DeviceBioFire Diagnostics, LLCUS:DE, AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA,…Official notice → - 2023-08-30
- US
BioFire Diagnostics, LLC recalls BioFire Respiratory Panel 2.1 (RP2.1), REF: 423742, For FILMARRAY systems, IVD, Rx Only
Due to manufacturing issue, panels may result in false negative results.
FDA · DeviceBioFire Diagnostics, LLCUS: CA CO CT FL GA IA IL IN LA MA MI MO MT NC NE NJ NM NY OH OK PA TN UT WV…Official notice →
Other drugs & medical recalls in the United States
- 2023-12-13
- US
Wilson-Cook Medical Inc. recalls QUANTUM TTC BILIARY BALLOON DILATOR, REF QBD-4X3, Order Number G22654; used to dilate strictures of the biliary tree
Nonconforming devices while manufactured correctly, do not comply to their design requirements. Potential harms associated with balloon detachment are endoscopic retrieval of an impacted or non-impacted object,…
- US
Thor Photomedicine Ltd recalls NovoTHOR Gen 2.5 Regular whole body red light therapy bed, model S2183
Failure of ball stud components causing the gas strut on one side to detach from the canopy, making the canopy difficult to lift.
FDA · DeviceThor Photomedicine LtdWorldwide Distribution: US (Nationwide): Arizona, California, Colorado,…Official notice → - US
IHB OPERATIONS B.V. recalls Freedom Boom models series: F110, F120, F130, F320, F330, F350, F410, and F420 with built in 42A Lightweight Spring Arm part numbers…
Weakened connection point on the adjustable suspension arm, potentially causing damage or a break.
FDA · DeviceIHB OPERATIONS B.V.US: AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, LA, MA, MB, MD, ME, MI,…Official notice → - US
AURIS HEALTH INC recalls Monarch Platform REF MON-000006 100-240V- 50/60Hz 1440w
Their is the potential that software issues may result in flipped image of the virtual Bronchoscope view.
FDA · DeviceAURIS HEALTH INCUS Distribution: AK, AL, AZ, CA, CO, CT, DC, DE, FL, GA, IL, IN, KY, MA, MI,…Official notice → - US
Elekta, Inc. recalls ELEKTA LIMITED Elekta Infinity, REF XRT 0511, XRT 0521, XRT 0531, XRT 0541; Medical Charged-Particle Radiation Therapy System Accelerator,…
Elekta has identified that if the microswitch within the middle arm is incorrectly setup, there is a potential for an uncontrolled extension of iViewGT / XVI detector arms. When the detector arm is fully deployed there…
- US
Abiomed, Inc. recalls Automated Impella Controller (AIC), product number 0042-040-US with software versions V8.4 and V8.4.1.
Pump not detected as connected to controller due to software issue.