Beckman Coulter Inc. recalls DxC 500 AU Clinical Chemistry Analyzer, Catalog Numbers/UDI codes: C63519 / 14987666545058 C63520 / 14987666545065. The Beckman Coulter…
Beckman Coulter is recalling their DxC 500 AU Clinical Chemistry Analyzer because a software error causes the analyzer to not run a requested calibration order in the following scenario: when a reagent blank or…
Read the official notice →- Date
- 2025-05-21
- Country
- United States
- Brand
- Beckman Coulter
- Product
- DxC 500 AU Clinical Chemistry Analyzer, Catalog Numbers/UDI codes: C63519 / 14987666545058 C63520 / 14987666545065. The Beckman Coulter…
- Classification
- Class II
- Units
- U.S: AL, CA, GA, ID, IN, LA, MA, MI, MN, MT, NC, NV, PA, PR, TN , TX, and WI…
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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 recalls
- 2025-06-18
US
Beckman Coulter, Inc. recalls DxI 9000 Access Immunoassay Analyzer, Catalog Number C11137, running software versions 1.20
A new motor/encoder and cable was introduced into instruments manufactured starting with serial number 300141 incorrectly. This incorrect installation is introducing error codes for the Dxl 9000 which prevents the…
FDA · DeviceBeckman Coulter, Inc.Worldwide distribution: US (Nationwide) and OUS Global (Foreign) to countries…Official notice →- 2025-06-11
US
Beckman Coulter, Inc. recalls DxI 9000 Access Immunoassay Analyzer, Catalog Number C11137, running software version 1.20
A new software update (v1.20) is introducing error codes for the Dxl 9000 which prevents the assay from being performed and a delay in results from being generated, and may require field service to resolve the delay.
FDA · DeviceBeckman Coulter, Inc.Worldwide Distribution: US (Nationwide) and OUS (Global) to countries of:…Official notice →US
Beckman Coulter, Inc. recalls Access Testosterone assay, Catalog Number 33560
Inadequate preventative maintenance (PM) performed on the scales of the RPL5 fill line, led to splashing (cross-contamination) between the wells of testosterone reagent packs lot 538081, which could potentially result…
- 2025-05-07
US
Beckman Coulter Inc. recalls DxC 500 AU Clinical Chemistry Analyzer, Catalog Numbers/UDI codes: C63519 / 14987666545058 C63520 / 14987666545065 Software versions:…
The reason for the recall is incorrect sample barcode identification and processing errors that result in the reporting of erroneous and delayed results.
FDA · DeviceBeckman Coulter Inc.Worldwide - U.S. Nationwide distribution including in the states of AL, CA,…Official notice →- 2025-04-30
US
Beckman Coulter, Inc. recalls Beckman Coulter DxI 9000 Access Immunoassay Analyzer
When DxI 9000 Access Immunoassay Analyzer is connected to a host system (laboratory information system (LIS) or middleware) and has accumulated canceled QC test results that were not sent by LIS, the analyzer may lose…
- 2025-04-16
US
Beckman Coulter, Inc. recalls DxI 9000 Access Immunoassay Analyzer, catalog number C11137 in vitro diagnostic device used for the quantitative, semi-quantitative, or…
Ground screws on Dxl 9000 PCB boards may cause electric shorts, leading to smoke and potentially delaying patient results. Smoke also poses a hazard to equipment and users.
FDA · DeviceBeckman Coulter, Inc.OUS (Foreign) distribution to countries of: Australia, Croatia, Czechia,…Official notice →
Other drugs & medical recalls in the United States
- 2025-05-28
US
Zydus Pharmaceuticals (USA) Inc recalls Esomeprazole Magnesium for Delayed-Release Oral Suspension, 20 mg, 30-count single dose packets per carton, Rx Only,…
Failed Impurities/Degradation Specifications: Out-of-Specification test results obtained for any individual unknown degradation product during Related Compounds testing during long term stability.
US
CareFusion 213, LLC recalls BD ChloraPrep Clear, 2% x/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA), Patient Preoperative Skin Preparation,…
Lack of Assurance of Sterility: The affected product may exhibit an open seal on the packaging of the applicator.
US
- 2025-05-21
US
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls Intera 1.5T Master/Nova, Model Number: 781106;
The Quadrature Body Coil (QBC) seal adhesive may fail, creating sharp edges that may come in contact with patients. If the QBC seal becomes loose during the scanning process, the risk to the patient may include skin…
FDA · DevicePHILIPS MEDICAL SYSTEMS NEDERLAND B.V.US: Nationwide Distribution International: Algeria, Andorra, Argentina,…Official notice →US
Klinika Mdical Gmb recalls KliniTray Platte Faxitron ,groB "R" sterile. Tissue resection margin examination board/large Model Number: 2001155-F The medical device…
Potential for microbial contamination.
FDA · DeviceKlinika Mdical GmbUS Nationwide distribution in the state of Massachusetts.Official notice →US
MEDLINE INDUSTRIES, LP - Northfield recalls Centurion Sterile Weitlaner Retractor 3 x 4 Prong, Reorder: I68395
Three is the potential for the retractors to puncture through the sterile packaging.