Beckman Coulter Inc. recalls REMISOL Advance UDI-DI code: 13700962601874 All Software Versions: B92487; B92488; C24317; C28652; C37500; D04164; C44703; C57017; C69412;…
Due to a software issue, the software may incorrectly process the date of birth (DoB) received from the Laboratory Information System (LIS) and when the DoB is set to 01/01/1900 or left empty, REMISOL Advance may…
Read the official notice →- Date
- 2025-07-02
- Country
- United States
- Brand
- Beckman Coulter
- Product
- REMISOL Advance UDI-DI code: 13700962601874 All Software Versions: B92487; B92488; C24317; C28652; C37500; D04164; C44703; C57017; C69412;…
- Classification
- Class II
- Units
- Worldwide - U.S. Nationwide distribution including in the states of AK, AL,AR,…
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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.
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- 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
- 2025-08-13
USBeckman Coulter Inc. recalls UIBC (Unsaturated Iron Binding Capacity), REF: OSR61205,
Beckman Coulter identified that the Unsaturated Iron Binding Capacity (UIBC) assay is not meeting their labeled hemoglobin interference claims of no significant interference (i.e., less than 10%) up to 200 mg/dL…
FDA · DeviceBeckman Coulter Inc.US: AK, AL, AR, CO, CT, DC, DE, ID, UT OUS: Algeria, Argentina, Australia,…Official notice →- 2025-07-30
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Beckman Coulter Inc. recalls Estrone RIA, REF: DSL8700. Estrone RIA is an IVD used for the quantitative measurement of estrone in human serum and plasma.
A specific lot of bovine serum albumin (BSA) used for manufacturing of coated tubes (CT) that are included in the Estrone RIA kit lots caused different affinity of manufactured coated tubes to patient samples, causing…
FDA · DeviceBeckman Coulter Inc.US: North Carolina OUS: Argentina, Austria, Belgium, Canada, France, Germany,…Official notice → - 2025-07-23
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Beckman Coulter, Inc. recalls Access Vitamin B12 Reagent, Catalog Number 33000, Lot Number 439850
Beckman Coulter has received complaints of erroneous Vitamin B12 results when using Access Vitamin B12 Reagent lot 439850. The affected reagent lot may cause erroneously low or high Vitamin B12 results, leading to a…
FDA · DeviceBeckman Coulter, Inc.International distribution to the country of Andorra, Bulgaria, Denmark,…Official notice → - 2025-07-02
- US
Beckman Coulter, Inc. recalls DxI 9000 Access Immunoassay Analyzer C11137
Analyzer has calibration issues where curves switched from passed to failed due to system errors during aspiration. This anomaly causes erroneous results and delays if unnoticed. RLU values may be misinterpreted as…
FDA · DeviceBeckman Coulter, Inc.Worldwide - US Nationwide distribution in the states of AR, CA, FL, GA, HI,…Official notice → - 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 →
Other drugs & medical recalls in the United States
- 2025-07-02
- US
Philips North America Llc recalls Spectral CT. Computed tomography X-ray system.
Devices with affected software may experience two unintended motion issues that may lead to contact between the Gantry or table with the operator or patient, along with additional software issues that affect CT…
FDA · DevicePhilips North America LlcDomestic: AZ, CA, CO, FL, GA, HI, IN, KY, MA, MD, MN, NY, OH, OR, PA, TX, VT,…Official notice → - US
Jewel Precision Sheet Metal & Machining Co, Inc. recalls Jewel Precision Reusable Rigid Sterilization Container System. Model Number: JP-24-8.
The 8-inch model of the Jewel Precision Reusable Rigid Sterilization Container System (i.e., model number: JP-24-8) was not cleared by the FDA. The letter to file justifying the change in size was insufficient.
FDA · DeviceJewel Precision Sheet Metal & Machining Co, Inc.US distribution to Tennessee.Official notice → - US
GE Medical Systems China Co., Ltd. recalls GE Healthcare LOGIQ F R3 Ultrasound System, Model/Catalog Number 5943263, diagnostic ultrasound system
GE HealthCare has become aware that the Estimated Fetal Weight (EFW) measurement data feature on the Versana Premier R3 and LOGIQ F R3 series ultrasound systems can display previous obstetric patient data in the Whizz…
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Siemens Healthcare Diagnostics, Inc. recalls Product: Atellica CH Diluent - CONS 2 x 1.5L; Siemens Material Number (SMN): 11099300;
Contamination of the diluent by sodium hypochlorite (NaOCl) which may impact calibrator, quality control (QC), and patient results for all assays except for sodium, potassium, and chloride.
FDA · DeviceSiemens Healthcare Diagnostics, Inc.Worldwide distribution - US Nationwide and the countries of Canada, Bahamas.Official notice → - US
Jewel Precision Sheet Metal & Machining Co, Inc. recalls Jewel Precision Reusable Rigid Sterilization Container System. Model/Catalog Number: JP-24-6.
The Instructions for Use do not match the 510(k) FDA cleared indications for use or sterility shelf life.
FDA · DeviceJewel Precision Sheet Metal & Machining Co, Inc.US Nationwide distribution in the states of IN, NY, PA.Official notice → - US
Limacorporate S.p.A recalls PRIMA 4MM ECCENTRICAL ADAPTOR WITH SCREW, REF:1367.15.704, Sterile
There is the potential that the eccentrical adaptor with screw, black laser marking, use to identify the position may be missing.
FDA · DeviceLimacorporate S.p.AWorldwide - US Nationwide distribution in the states of VA, FL, SC, MS, NY, TX…Official notice →