Beckman Coulter, Inc. recalls DxI 800 Access Immunoassay Analyzer W/Dual Gantry, Part Number A71457
Beckman Coulter has identified that the UniCel DxI 600/800 systems with linear slide PnP gantries running software versions 5.7 and up faced incorrect PnP X-motor current settings where the PnP X-motor current…
Read the official notice →- Date
- 2025-08-13
- Country
- United States
- Brand
- Beckman Coulter
- Product
- DxI 800 Access Immunoassay Analyzer W/Dual Gantry, Part Number A71457
- Classification
- Class II
- Units
- Worldwide distribution - US Nationwide.
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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
- 2025-10-08
USBeckman Coulter Inc. recalls DxC 500 AU Module w/ISE, DxC 500i, With ISE, REF: C63522 and DxC 500 AU Module, DxC 500i, Without ISE, REF: C6352; part of the DxC 500i…
On a clinical analyzer, when ordering a Clinical Chemistry (CC) combination test simultaneously with an Immunoassay (IA) test, if the IA test is processed between the CC tests, CC sample status will remain In Progress…
FDA · DeviceBeckman Coulter Inc.Internationally distribution to the countries of Poland, India, Dominican…Official notice →- 2025-09-24
- US
Beckman Coulter Inc. recalls UniCel DxH 800 COULTER Cellular Analysis System, configured with the Led HGB Photometer REFs:B24802, 629029, B63322
Hematology analyzers configured with HGB photometers may result in erroneously high hemoglobin (HGB) results on samples with elevated white blood cell (WBC) counts.
FDA · DeviceBeckman Coulter Inc.Worldwide - US Nationwide distribution including in the states of AL, AZ, CA,…Official notice → - 2025-08-20
- US
Beckman Coulter, Inc. recalls Access Thyroglobulin assay, a simultaneous one-step immunoenzymatic assay, Catalog Number 33860
Access Thyroglobulin reagent lot 439163 may generate erroneously high patient results. Falsely increased Access Thyroglobulin results may lead a physician to pursue unnecessary diagnostic imaging studies and/or…
FDA · DeviceBeckman Coulter, Inc.Worldwide - US Nationwide and the countries of Brazil, Canada, Georgia, Italy,…Official notice → - 2025-08-13
- US
Beckman 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
- US
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
- US
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 →
Other drugs & medical recalls in the United States
- 2025-08-13
- US
Intersurgical Inc recalls One-piece Guedel airway, size 2, ISO 8.0, green. Model Number: 1112080.
Potential contamination with small burrs, which if detach could be inhaled and result in potential complications such as airway obstruction, tissue irritation, inflammation and infection.
FDA · DeviceIntersurgical IncUS distribution to AZ, CA, CT, FL, FL, HI, MA, MI, OH, UT, VA.Official notice → - US
Nuclein LLC recalls DASH SARS-CoV-2 & Flu A/B Test Model/Catalog Number: SG-0006 combination COVID-19 and Flu test. Each DASH SARS-CoV-2 & Flu A/B Test is…
Due to manufacturing error, assay test may result in missed diagnosis or delay of treatment. (Potential false negative result)
FDA · DeviceNuclein LLCUS distribution to: Florida, New York, Texas, and West VirginiaOfficial notice → - US
Siemens Healthcare Diagnostics Inc recalls epoc BGEM BUN Test Card [25pk]. Material Number: 10736515.
Siemens Healthcare Diagnostics Inc. has confirmed that a negative sodium bias may exist in some epoc test card lots. All other analytes are performing as intended. The observed average bias for sodium was -4.4 mmol/L.…
FDA · DeviceSiemens Healthcare Diagnostics IncWorldwide distribution - US Nationwide and the countries of Argentina,…Official notice → - US
DRG International, Inc. recalls Brand Name: T4 Total ELISA Product Name: T4 Total ELISA Model/Catalog Number: EIA-4568 Product Description: T4 Total ELISA
An incoming complaint reported that the expiration date on the kit box label and Certificate of Analysis (CoA) exceeded the shelf life of the standards and control solutions in the kit by 2 months (i.e., 2026-03-31…
FDA · DeviceDRG International, Inc.Worldwide - US Nationwide distribution in the states of CA, MA, PA and the…Official notice → - US
Beckman 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 → - US
AVID Medical, Inc. recalls GYN ROBOTIC PACK. Medical convenience kit.
CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration.