BECKMAN COULTER LABORATORY SYSTEMS (SUZHOU) CO., LTD. recalls DxC 500 AU Clinical Chemistry Analyzer, REF: C63519, and C63520 with affected software.
Beckman Coulter has identified an issue which prevents the DxC 500 AU instrument from providing the correct onboard stability (Open Expiration) dates for assays that were loaded prior to a software upgrade (e.g. 1.3 to…
Read the official notice →- Date
- 2025-03-05
- Country
- United States
- Brand
- BECKMAN COULTER LABORATORY SYSTEMS (SUZHOU) CO., LTD.
- Product
- DxC 500 AU Clinical Chemistry Analyzer, REF: C63519, and C63520 with affected software.
- Classification
- Class II
- Units
- US: MA, CA, SC, LA, OK, GA, AL, TX, OR, ID, CO, MN, NY, MS, PA, WA, IL, MI,…
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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
- 2025-03-05
USGE Healthcare (China) Co., Ltd. recalls Brivo MR355, NMRI system
For certain MR systems, a scan can be resumed following a Power Monitor trip when the "6-minute average SAR" is above the limit indicated on the "SAR Display". The user interface may incorrectly enable a scan to…
FDA · DeviceGE Healthcare (China) Co., Ltd.Domestic US distribution nationwide. International distribution worldwide.Official notice →- US
Pentax of America Inc recalls Pentax Medical Video Processor- Intended to be used with PENTAX Medical endoscopes, monitors and other peripheral devices for endoscopic…
During endoscopic procedures using a combination of the video processor EPK-i8020c and the i20c series video endoscope, the observed image can become reddish or dark (1.8%). Users have observed smoke-like steam and…
- US
Scientia Vascular, Inc. recalls Plato 17 Microcatheter REF PL17-160-090 To assist in delivery of therapeutic devices and embolization materials and infusion of…
Due to manufacturing non-conformance that resulted in channels in the seal on the packaging pouch. As a result, this could potential create a breach in the sterile barrier.
FDA · DeviceScientia Vascular, Inc.U.S. Nationwide distribution in the state of DE.Official notice → - US
Physio-Control, Inc. recalls LIFEPAK 20e REF 99507-000001 The AED mode is to be used only on patients in cardiopulmonary arrest.
Incorrect keypad was incorrectly installed onto a defibrillator/monitor.
- US
CareFusion 303, Inc. recalls BD Alaris Pump Module REF 8100 The BD Alaris System with Guardrails Suite MX is a modular infusion pump and monitoring system for the…
Due to User Manual/Direction for Use incorrectly instructing user to leave the safety clamp in the open position when reloading an infusion set. This issue potentially could result in an accidental over infusion if the…
FDA · DeviceCareFusion 303, Inc.U.S.: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, GU, HI, IA, ID, IL, IN, KS,…Official notice → - US
CareFusion 303, Inc. recalls 138913-01 BD PYXIS MEDBANK MINI CR-2HH-1FH-P 169-114 BD PYXIS MEDBANK MINI CR-2HH-1FH-P 138911-01 BD PYXIS MEDBANK MINI CR-4HH-P 169-115…
Labeling update to include a contraindication statement against the use of medicine cabinets in procedure and operating rooms.
FDA · DeviceCareFusion 303, Inc.US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO,…Official notice →