Phadia Ab recalls EliA GBM Wells, Material Number 14551401, for Phadia 250, 2500, and 5000. In vitro diagnostic
Complaints that specific samples produced false positive EliA GBM results. A positive signal was present when these samples were tested for coating-solution reactivity using EliA wells without antigen.
Read the official notice →- Date
- 2024-01-31
- Country
- United States
- Brand
- Phadia Ab
- Product
- EliA GBM Wells, Material Number 14551401, for Phadia 250, 2500, and 5000. In vitro diagnostic
- Classification
- Class II
- Units
- US Nationwide.
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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.
Other drugs & medical recalls in the United States
- 2024-01-31
USKENT IMAGING, INC. recalls Snapshot NIR, REF: KD204
Tissue oxygenation measurement system touchscreens may be unresponsive, which may prevent the viewing of oxygenation images.
FDA · DeviceKENT IMAGING, INC.Worldwide - US Nationwide distribution in the states of IN, OH, TX, PA, WI,…Official notice →- US
Ossur H / F recalls Power Knee, REF: PKA10001, and PKA10003; with Power Knee Battery, REF: PKA10002
Knee batteries may need replacement with conforming batteries to ensure there isn't a failure to turn on the device, or an unexpected shutdown, which is a momentary loss of power to the knee where the user may…
FDA · DeviceOssur H / FUS Nationwide distribution including in the states of MA, SC, MD, TN, ND, VA,…Official notice → - US
Beckman Coulter, Inc. recalls Beckman Coulter DxU 850m/840m Microscopy Analyzers, Part Numbers: C49513, C76947
Beckman Coulter has become aware that the cannula, which is found in the Flowcell and the iQClear Rinse Waste Well Assembly, may rust. Rust from the cannula has the potential to generate erroneous results.
FDA · DeviceBeckman Coulter, Inc.US and Australia, Brazil, Canada, China, France, Germany, Ghana, India,…Official notice → - US
Hologic, Inc. recalls PANTHER FUSION System REF 9121010000 The Panther System is an integrated nucleic acid testing system which fully automates all steps…
Due to potential false positive Flu B results when a sample was also SARS-CoV-2 positive.
FDA · DeviceHologic, Inc.Worldwide - U.S. Nationwide distribution including in the states of AK, AR,…Official notice → - US
SEDECAL SA recalls Sedecal X Optima URS digital mobile diagnostic x-ray system. A a stationary x-ray unit with a universal swivel arm. It allows one to take…
Some parts have fallen off the equipment resulting in a safety risk to patients and/or users.
FDA · DeviceSEDECAL SADistribution was made to AL, FL, and NC. There was no military/government…Official notice → - US
Medtronic Neuromodulation recalls Model A710 Intellis Clinician Programmer Application, version 2.0.97
Medtronic has discovered an instance in which the Intellis A710 Clinician Programmer Application (CP App) could no longer establish a session with the Implantable Neurostimulator (INS) which resulted in the inability…