BioFire Diagnostics, LLC recalls Generic Name: BioFire¿ Joint Infection (JI) Panel Generic Name: BioFire¿ Joint Infection (JI) Panel Model/Catalog Number: RFIT-ASY-0138…
Due to potential contaiminated of spefic lots of pneumonia and joint infection panels that could result in false positive results
Read the official notice →- Date
- 2026-10-21
- Country
- United States
- Brand
- BioFire Diagnostics
- Product
- Generic Name: BioFire¿ Joint Infection (JI) Panel Generic Name: BioFire¿ Joint Infection (JI) Panel Model/Catalog Number: RFIT-ASY-0138…
- Classification
- Class II
- Units
- Worldwide - U.S. Nationwide distribution including in the states and territory…
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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
- 2026-08-19
BioFire Diagnostics, LLC recalls BIOFIRE Respiratory Panel 2.1 (RP2.1) REF 423742 UDI code: 00815381020529 PCR-based multiplexed nucleic acid test, in vitro diagnostic
Due to increase in false negative results
FDA · DeviceBioFire Diagnostics, LLCU.S. Nationwide distribution in the states of AL, AR, IA, IL, KS, LA, MN, MO,…Official notice →- 2026-05-13
BioFire Diagnostics, LLC recalls Biofire Spotfire Respiratory/Sore Throat Panel REF: 423485
Respiratory/sore throat panel test may result in false negative results and control failures.
FDA · DeviceBioFire Diagnostics, LLCUS Nationwide distribution in the states of MS, TX MN, VA.Official notice →BioFire Diagnostics, LLC recalls BioFire Joint Infection (JI) Panel REF: RFIT-ASY-0138, 30 test Kit.
Contamination to in-vitro diagnostic test may result in false positives.
FDA · DeviceBioFire Diagnostics, LLCWorldwide - US Nationwide distribution in the states of TX, NC, UT, MD and the…Official notice →- 2025-12-03
BioFire 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
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
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 →
USOther drugs & medical recalls in the United States
- 2026-10-21
Steris Corporation recalls RAPICIDE PA Part A High-Level Disinfectant, Model/Catalog Number: ML020115
If the vented cap becomes blocked, gas may accumulate and the bottle may swell due to increased internal pressure. In some cases, excess vapor or liquid chemistry may escape from the bottle when the cap is twisted…
Ethicon, LLC recalls PERMA-HAND Silk Black Braided Sterile Nonabsorbable Surgical Suture, 1X18" TF-5, Product Code: N271H
Silk sutures, indicated for use in cardiovascular, ophthalmic and neurological procedures, packaged with alcohol-based fluid, not part of product design, that if discovered prior to use may cause surgical delay. If…
FDA · DeviceEthicon, LLCWorldwide - US Nationwide distribution in the states of SC, PA, TX, CA, ID,…Official notice →Baxter Healthcare Corporation recalls Likorall Overhead Lifts Product Code: 3121001 Product Description: LIKORALL 200 Product Code: 3122005 Product Description:…
Potential issue involving motor shaft breakage combined with reduced performance of the Single Fault Safety (SFS) system may lead to instances where the lift strap lowers more quickly than expected during use. Patients…
FDA · DeviceBaxter Healthcare CorporationWorldwide - US Nationwide distribution including in the states of Alabama,…Official notice →INTEGRATED MEDCRAFT LLC recalls FORWARD Gunshot Wound Kit; Model: AFT-GSW;
Subrecall of a kitted device from SafeGuard Medical due to internal testing identified an issue affecting the device's sterile pad, potentially causing the sterile pad to degrade over time. The degradation may cause…
FDA · DeviceINTEGRATED MEDCRAFT LLCUS Nationwide distribution in the states of GA, VA.Official notice →SI-BONE, Inc. recalls iFuse TORQ Implant System Model/Catalog Number: 10055T(10x55mm), 10060T(10x60mm), 10065T(10x65mm), 10080T(10x55mm), 11580T(11.5x80mm)
The pelvic fixation screws failed to meet acceptance criteria for tube packaging seal integrity testing; therefore, sterility assurance cannot be ensured.
FDA · DeviceSI-BONE, Inc.US Nationwide distribution in the states of FL, GA, HI, NC, OH, PA, SD, TX, VA.Official notice →Ferno-Washington Inc recalls Power F2 Powered Fastening System, Power F2, Item No. 0567093 used with Power X2 Stretchers, Power X2, Item No. 0015816 and PowerX2…
Firmware issue may result in intermittent loss or degradation of powered functionality when paired with compatible stretcher. The issue may lead to the system not operating in powered mode, or exhibiting reduced…
FDA · DeviceFerno-Washington IncWorldwide - US Nationwide distribution in the states of AL, AR, AZ, CA, CO,…Official notice →