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…
Read the official notice →- Date
- 2024-08-07
- Country
- United States
- Brand
- BioFire Diagnostics
- Product
- BIOFIRE Blood Culture Identification 2 (BCID2) Panel, REF: RFIT-ASY-0147, for FILMARRAY Systems, when used in conjunction with Culture…
- Classification
- Class II
- Units
- Worldwide - US Nationwide distribution including in the states of FL, IL, KY,…
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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
- 2024-09-18
USBioFire 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 →- 2024-08-28
- US
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
- 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 → - 2024-02-21
- 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 → - 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…
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 →
Other drugs & medical recalls in the United States
- 2024-08-14
- US
Dr. Reddy's Laboratories, Inc. recalls Sevelamer Carbonate for Oral Suspension 0.8g packets, packaged in 90 packets per container, Distributor: Dr. Reddy's Laboratories…
Labeling: Incorrect or Missing Lot and/or Exp Date. Missing lot number and expiration dates on packets
- 2024-08-07
- US
Becton Dickinson Infusion Therapy Systems, Inc. recalls BD Insyte Autoguard BC, Shielded IV Catheter with Blood Control Technology, REF: 382533, 20 GA x 1.00 in (1.1x25…
Catheters may contain a hole in the catheter tubing, which could result in leakage during the insertion process.
- US
Medivance Inc. recalls Arctic Sun Temperature Management Systems, Name/REF: Arctic Sun STAT, NA/6000-00-00; Arctic Sun STAT Loaner, NA/6000-00-00L; Arctic Sun…
If temperature management system fails to reach correct target water temperature while device is operating in patient control mode, due to sudden patient temperature changes/interruption in water flow/blockage of air…
FDA · DeviceMedivance Inc.Worldwide - US Nationwide distribution including in the states of IN, OK, MO,…Official notice → - US
Beckman Coulter Mishima K.K. recalls DxC 500 AU Clinical Chemistry Analyzer, REF C63520 is an automated chemistry analyzer that measures analytes in samples, in…
There are two software bug issues with the analyzer. Issue 1: When a dedicated rack is reserved for calibration, after a calibration test has been placed and completed, the same rack may be used to place both a patient…
FDA · DeviceBeckman Coulter Mishima K.K.Worldwide - U.S. Nationwide distribution in the states of AL, CA, GA, HI, IL,…Official notice → - US
Angiodynamics, Inc. recalls SOFT-VU KUMPE 5F X 40CM -Used for patients in need of angiographic diagnosis. Catalog Number: 10732702
Mislabeled. The shelf-box labeling (unit of sale) is accurate for the packaged devices, however the inner pouch label may contain information for a different model (catheter length)
- US
Boston Scientific Corporation recalls Capio SLIM Suture Capturing Device, Box of 5, Outer Package UPN: M0068318261, Inner Package UPN: M0068318260. Capio SLIM Suture…
Some lots of Capio SLIM do not consistently catch the suture after activation possibly resulting in a prolonged procedure or additional medical intervention.
FDA · DeviceBoston Scientific CorporationDomestic: Nationwide Distribution. International: PendingOfficial notice →