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…
Read the official notice →- Date
- 2024-01-17
- Country
- United States
- Brand
- BioFire Diagnostics
- Product
- 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 or…
- Classification
- Class II
- Units
- US: NC, MO, NE, CT, IL, TN, NJ, OH, MA, CA, FL, UT, IA, KS, TX, MD
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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
- 2024-02-21
USBioFire 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 →- US
BioFire Diagnostics, LLC recalls BIOFIRE Blood Culture Identification 2 (BCID2) Panel when used with: BD BACTEC Lytic Anaerobic medium BD BACTEC Peds Plus medium BD…
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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 → - 2023-12-13
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BioFire Diagnostics, LLC recalls BIOFIRE Blood Culture Identification 2 (BCID2) Panel, REF: RFIT-ASY-0147, used with Maine Molecular Quality Controls, Inc (MMQCI)…
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FDA · DeviceBioFire Diagnostics, LLCWorldwide Distribution: US (nationwide): DE, OH, NY, IL, KY, FL, GA, KS, CA,…Official notice → - 2023-11-29
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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…
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FDA · DeviceBioFire Diagnostics, LLCWorldwide - U.S. Nationwide distribution including in the states of AK, AL,…Official notice → - 2023-09-20
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BioFire Diagnostics, LLC recalls FILMARRAY Gastrointestinal (GI) Panel (Part No.: RFIT-ASY-0104 & RFIT-ASY-0116) Pouch Module Software
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Other drugs & medical recalls in the United States
- 2024-01-17
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MEDLINE INDUSTRIES, LP - Northfield recalls Medline Gown Poly W/Breath Sleeves XL AAMIK Level 4 (Eclipse gown), REF SPT-2208CS, 100/pack, Non-Sterile.
Surgical gowns were manufactured with the wrong sleeve.
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Baxter Healthcare Corporation recalls XScribe CP Cardiac Stress Testing System, version 6, with below product names and codes: a) X-SCRIBE CPI KIT WIRELESS USB 608 MHz,…
Potential distortion identified in electrocardiogram (ECG) readings when the Source Consistency Filter (SCF) is enabled.
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