Abbott 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.
Read the official notice →- Date
- 2022-03-09
- Country
- United States
- Brand
- Abbott Molecular
- Product
- Alinity m Integrated Reaction Units (IRU)
- Classification
- Class II
- Units
- US Nationwide distribution in the states of AZ, CA, CO, CT, DC, FL, GA, IL,…
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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
- 2022-08-24
US
Abbott Molecular, Inc. recalls The Alinity m System, REF 08N53-002, For In Vitro Diagnostic Use.
Incorrect optical calibration
- 2022-04-13
US
Abbott Molecular, Inc. recalls Alinity m HBV AMP Kit (US and CE)
There is a potential for misquantitation high results for negative samples.
FDA · DeviceAbbott Molecular, Inc.US consignees - AZ, CA, IL, IN, MA, MI, MO, NH, NJ, NY, OH, SD, TX, and VA OUS…Official notice →US
Abbott Molecular, Inc. recalls Alinity m HBV Application Specification File (US and CE)
There is a potential for misquantitation high results of negative samples.
FDA · DeviceAbbott Molecular, Inc.US consignees - AZ, CA, IL, IN, MA, MI, MO, NH, NJ, NY, OH, SD, TX, and VA OUS…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 →
Other drugs & medical recalls in the United States
- 2022-03-09
US
Stryker Leibinger GmbH & Co. KG recalls MEDPOR Titan OFW - MTB - Right - 1.0mm, Catalog number 81032
Inside the packaging of one reported item a non-conforming product was found. Contrary to the design, the barrier layer was manufactured on the inferior side of the implant versus the superior side.
US
Microbiologics Inc recalls KWIK-STIK, Quality control kit for culture media, sold as: KWIK-STIK (single-pack) Enterococcus faecalis derived from ATCC 51299
This strain should be resistant to high levels of Gentamicin and be resistant to Gentamicin Synergy. A specific lot was found susceptible to Gentamicin Synergy during in-house testing.
FDA · DeviceMicrobiologics IncWorldwide distribution - US Nationwide and the countries of Argentina,…Official notice →US
Hobbs Medical, Inc. recalls Bronchial Microbiology Brush, Catalog Number 4310 and 4320. Microbial sampling is performed by compressing a spring as the base of brush…
The labeling for the Microbiology Brush identifies the device as a Bronchial Microbiology Brush. The device is only cleared for gastrointestinal use and is not cleared for bronchial use.
US
Lacrimedics Inc recalls Collagen Plugs, CP3, 0.3mm, CP4, 0.4mm, CP5, 0.5 mm, Sterile, EO, Rx Only, CE Dry eye treatment
The sterile pouch seal may contain channels that could affect the seal integrity and potentially compromise sterility.
FDA · DeviceLacrimedics IncNationwide and Worldwide Distribution to following countries - AR. BE, BO, BR,…Official notice →US
Brasseler USA, Medical L.L.C. recalls Brasseler USA, K-WIRE, Double Trocar Smooth, REF KM172-26-35S
One lot of product was distributed in unsealed packaging
FDA · DeviceBrasseler USA, Medical L.L.C.US Nationwide distribution in the states of OH, MI, AZ, FL, CA, TN, TX, SC, PA…Official notice →US
K2M, Inc recalls Everest MI XT Inner Dilator, Catalog Number 5101-90167
Stryker received two (2) complaints for units from specific lots of Inner and Outer Dilators not fitting together properly during a surgical procedure. Some dilators from these lots and from other lots were…