Beckman Coulter Biomedical GmbH recalls PE Centrifuge Temperature Controlled, REF: B36366, a component of the Power Express.
The adhesive joint between the plastic socket and metal component of the Power Express Sample Holder can fail, causing the metal part to detach and enter the centrifuge. This detachment can result in damage to the…
Read the official notice →- Date
- 2024-09-11
- Country
- United States
- Brand
- Beckman Coulter Biomedical
- Product
- PE Centrifuge Temperature Controlled, REF: B36366, a component of the Power Express.
- Classification
- Class II
- Units
- Worldwide distribution - US Nationwide and the countries of Australia,…
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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 Beckman Coulter Biomedical recalls
- 2026-08-12
USBeckman Coulter Biomedical GmbH recalls REMISOL Advance with Software Version 2.5 UDI-DI code: 15099590802073 The Normand Info REMISOL Advance Data Manager collects and…
Due to software issues where does not handle combo assay results. The software may replace the final combo test result with one of the sub-results resulting in incorrect reporting of test outcomes.
FDA · DeviceBeckman Coulter Biomedical GmbHU.S.: FL, GA, IL, MI, and PA O.U.S.: Belgium, France, Hungary, Poland, Taiwan…Official notice →- 2023-07-26
- US
Beckman Coulter Biomedical GmbH recalls Beckman Coulter DxA Automation System, DxA 5000 Fit, REF: B87352, IVD, 200240V, 16A, 50/60HZ, RxOnly
A software defect in the DxA Automation System may cause tests to be run on patient samples in tube types not compatible with the requested test, leading to erroneous patient results
FDA · DeviceBeckman Coulter Biomedical GmbHUS: AL CA FL IL IN KY MI MN MO NE NJ NV NY OH PA SC TX WI WV OUS: Australia,…Official notice →
Other drugs & medical recalls in the United States
- 2024-09-18
- US
Olympus Corporation of the Americas recalls Olympus Triangle Tip Electrosurgical Knives- to be used with Olympus endoscopes and electrosurgical units to cut tissue using…
Due to increase in complaints for the KD-640L and KD-645L Triangle Tip Electrosurgical Knives breaking off during use -issuing reminder to users to utilize the electrosurgical knife in accordance with the Instructions…
- US
Elevate Oral Care recalls Just Right 5000, 1.1% Sodium Fluoride, Candy Apple Flavor, Net Wt. 3.4oz (97g), Rx Only, Manufactured for Elevate Oral Care, LLC in the…
LABELING: LABEL MIX-UP.
FDA · DrugElevate Oral Care120 direct customers, Nationwide US. No foreign, DOD/VA.Official notice → - US
PREQUEL SKIN recalls BARRIER THERAPY SKIN PROTECTANT CREAM (1% colloidal oatmeal), 10 FL OZ/296 ML- tube, Distributed By: Prequel, LOS ANGELES, CA 90069. UPC 8…
Microbial contamination of non-sterile Products -
- 2024-09-11
- US
Abiomed, Inc. recalls ImpellaCP SmartAssistSetAPAC, Delo1895; Product Code: 1000302;
A potential device interaction between the Shockwave Coronary IVL Catheter and left-sided Impella Pumps during coronary interventions. Currently there is no Abiomed labeling (IFU etc.) content related to this potential…
FDA · DeviceAbiomed, Inc.Worldwide distribution - US Nationwide and the countries of Australia,…Official notice → - US
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls Philips Azurion 7M20 systems with FlexArm ceiling-mounted system, Interventional Fluoroscopic X-Ray System, Model Numbers…
The motorized longitudinal movement of the FlexArm stand may be inconsistent (not smooth) and eventually may become unavailable. This issue is due to grease leakage from the bearings and/or anti-corrosion oil applied…
FDA · DevicePHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Worldwide - US Nationwide distribution.Official notice → - US
Mindray DS USA, Inc. dba Mindray North America recalls Sevoflurane E_Vap.(Safety Filling adapter) used with the A9 Anesthesia System-Used to provide the vapor of an…
V90 electronic vaporizer anesthetic agent output may be higher than the set amount due to a component within the vaporizer causing an incomplete seal in some cases. Should this issue occur, the A9 Anesthesia System…
FDA · DeviceMindray DS USA, Inc. dba Mindray North AmericaUS Distribution to states of: California, Georgia, Kentucky, Mississippi, New…Official notice →