Abbott Molecular, Inc. recalls Vysis CLL FISH Probe Kit with the following components: Vysis LSI p53 SpectrumOrange/ATM, SpectrumGreen and LSI D13S319, SpectrumOrange/…
Potential for Vysis CLL FISH Probe Kits not detecting 13q deletions in known positive patient samples.
Read the official notice →- Date
- 2021-10-06
- Country
- United States
- Brand
- Abbott Molecular
- Product
- Vysis CLL FISH Probe Kit with the following components: Vysis LSI p53 SpectrumOrange/ATM, SpectrumGreen and LSI D13S319, SpectrumOrange/…
- Classification
- Class II
- Units
- Worldwide distribution - US Nationwide distribution in the states of AZ, 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 Details may be shortened or out of date; the official notice is the authoritative source.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
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 Abbott Molecular recalls
- 2022-03-09
USAbbott Molecular, Inc. recalls Alinity m Integrated Reaction Units (IRU)
There is potential for the Reaction Vessels (RVs) detaching from the RV cap during transport by the pipettor robot.
FDA · DeviceAbbott Molecular, Inc.US Nationwide distribution in the states of AZ, CA, CO, CT, DC, FL, GA, IL,…Official notice →- 2022-01-12
- US
Abbott Molecular, Inc. recalls Alinity m System, Part No. 08N53-002
There is an issue with the installation of updated camera firmware on the system.
FDA · DeviceAbbott Molecular, Inc.Distribution in the United States in CA, DC, GA, KY, IL, MD, MI, MN, MS, NH,…Official notice → - US
Abbott Molecular, Inc. recalls Alinity m System, Part No. 08N53-002
There is a software defect that can cause the Amplification Detection clamp CLEAN position to be set too high.
FDA · DeviceAbbott Molecular, Inc.Worldwide distribution - US distribution and the countries of Australia,…Official notice → - US
Abbott Molecular, Inc. recalls Alinity m System, Part No. 08N53-002
There is a software issue associated with the ability to properly complete a Field Service Engineer Maintenance and Diagnostics procedure.
FDA · DeviceAbbott Molecular, Inc.Worldwide distribution - US Nationwide and the countries of Australia,…Official notice → - US
Abbott Molecular, Inc. recalls Alinity m System, Part No. 08N53-002
There is a potential for abnormal (non-sigmoidal) amplification curves.
FDA · DeviceAbbott Molecular, Inc.Worldwide distribution - US Nationwide and the countries of Australia,…Official notice → - 2021-10-20
- US
Abbott Molecular, Inc. recalls Alinity m SARS-CoV-2 Amp Kit (Non-US Assay) and Alinity m SARS-CoV-2 Application Specification File. in vitro diagnostic
There is a potential for false positive results.
FDA · DeviceAbbott Molecular, Inc.Worldwide Distribution. US Nationwide, AUSTRALIA, AUSTRIA, BELGIUM, BRAZIL,…Official notice →
Other drugs & medical recalls in the United States
- 2021-10-06
- US
Biodex Medical Systems, Inc. recalls Atomlab 500 Dose Calibrator Software 2.0.00 through Revision 2.0.08, inclusive Model: 086-330.
When deleting a previously entered custom isotope, the software deletes the isotope, but not the associated dial setting. Possible other stored custom isotopes may then have incorrect dial settings and may lead to an…
FDA · DeviceBiodex Medical Systems, Inc.Nationwide Foreign: Austria Autralia Brazil CANADA Chile Colombia Croatia…Official notice → - US
Aesculap Implant Systems LLC recalls PAS-PORT PROXIMAL ANASTOMOSIS SYSTEM Catalog Number: FC700SU
Malfuncton-Implant did not deploy successfully may necessitate the need for an additional medical intervention for patients which would result in a potential delay in surgery
FDA · DeviceAesculap Implant Systems LLCUS Nationwide distribution in the states of FL, MI, NY, TX, WI.Official notice → - US
IMPERATIVE CARE INC recalls Imperative Care, ZOOM 71 Reperfusion Catheter, REF: ICRC071137, TRX Tip, 137 cm, 6F (.083 in/2.11 mm), .071 in/1.8 mm), STERILE.EO, Rx…
There is a potential for distal end of catheters to fracture and become detached.
- US
Medline Industries Inc recalls NAMIC Stopcocks: (1) NAMIC STOPCOCK, 200 psi (14 bar), REF 70015002, UPN H965700150021, Three-way Stopcock with Rotating Collar, Rx only,…
Potential for sterile barrier breach. Microscopic pinholes within the sterile pouch could potentially lead to non-sterile conditions.
FDA · DeviceMedline Industries IncWorldwide distribution - US Nationwide distribution and the countries of…Official notice → - US
Olympus Corporation of the Americas recalls BF-XP60 OES Bronchofiberscope, Model No. BF-XP60
The firm is issuing validated, new reprocessing instructions according to the FDA 2015 guidance, "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling."
FDA · DeviceOlympus Corporation of the AmericasDomestic distribution nationwide. Product also distributed globally.Official notice → - US
Elekta Inc recalls Elekta Monaco - Product Usage: used to make treatment plans for patients with prescriptions for external beam radiation therapy.
Contour changes can be saved on an unintended image set. In addition, these contour edits do not cause the dose to be frozen on the plans associated with that image set.
FDA · DeviceElekta IncWorldwide distribution - US Nationwide distribution in the states of PA, MI,…Official notice →